RTA guidance

Premarket Notification Submission 510(k), Subpart E

RTA guidance

OMB: 0910-0120

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Contains Nonbinding Recommendations

Refuse to Accept Policy for 510(k)s
Guidance for Industry and
Food and Drug Administration Staff
Document issued on: September 13, 2019.
Document originally issued on May 20, 1994.
This document supersedes “Refuse to Accept Policy for 510(k)s” issued
February 21, 2019.
For questions about this document regarding CDRH-regulated devices, contact ORP: Office of
Regulatory Programs, DRP1: Division of Submission Support, Premarket Notification and
Classification Team by email at [email protected] or at 301-796-5640.
For questions about this document regarding CBER-regulated devices, contact the Office of
Communication, Outreach, and Development (OCOD) by email at [email protected] or at 800835-4709 or 240-402-8010.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

Contains Nonbinding Recommendations

Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852.
Identify all comments with the docket number FDA-2012-D-0523. Comments may not be acted
upon by the Agency until the document is next revised or updated.

Additional Copies
Additional copies are available from the Internet. You may also send an e-mail request to
[email protected] to receive a copy of the guidance. Please include the document
number 1793 and complete title of the guidance in the request.
Additional copies are available from the Center for Biologics Evaluation and Research (CBER),
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave.,
WO71, Room 3128, Silver Spring, MD 20903, or by calling 800-835-4709 or 240-402-8010, by
email, [email protected], or from the Internet at https://www.fda.gov/vaccines-bloodbiologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

Contains Nonbinding Recommendations

Table of Contents
I. Purpose ........................................................................................................................................ 5
II. Background ................................................................................................................................ 6
III. Scope ......................................................................................................................................... 7
IV. Q-submission Interaction .......................................................................................................... 7
V. 510(k) Refuse to Accept Policies and Procedures ..................................................................... 8
VI. Refuse to Accept Principles .................................................................................................... 11
VII. The Checklist – Preliminary Questions ................................................................................. 13
VIII. The Checklists – Acceptance Review .................................................................................. 15
Appendix A. Acceptance Checklist for Traditional 510(k)s ................................................... 21
Appendix B. Acceptance Checklist for Abbreviated 510(k)s .................................................. 56
Appendix C. Acceptance Checklist for Special 510(k)s ........................................................... 92

Contains Nonbinding Recommendations

Refuse to Accept Policy for 510(k)s
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA
or Agency) on this topic. It does not establish any rights for any person and is not binding
on FDA or the public. You can use an alternative approach if it satisfies the requirements
of the applicable statutes and regulations. To discuss an alternative approach, contact the
FDA staff or Office responsible for this guidance as listed on the title page.

I. Purpose
The purpose of this document is to explain the procedures and criteria FDA intends to use in
assessing whether a premarket notification (510(k)) submission meets a minimum threshold
of acceptability and should be accepted for substantive review.
Focusing FDA’s review resources on complete submissions will provide a more efficient
approach to ensuring that safe and effective medical devices reach patients as quickly as
possible. Moreover, with the enactment of the Medical Device User Fee and Modernization
Act of 2002 (MDUFMA), the Medical Device User Fee Amendments of 2007 (MDUFA II),
the Medical Device User Fee Amendments of 2012 (MDUFA III), and the Medical Device
User Fee Amendments of 2017 (MDUFA IV), 1 FDA agreed to performance goals based on
the timeliness of reviews. Acceptance review therefore takes on additional importance in
both encouraging quality submissions from submitters of 510(k) notifications and allowing
FDA to appropriately concentrate resources on complete submissions.
Therefore, the current 510(k) Refuse to Accept (RTA) policy includes an early review
against specific acceptance criteria and to inform the submitter within the first 15 calendar
days after receipt of the submission if the submission is administratively complete, or if not,
to identify the missing element(s). In order to enhance the consistency of our acceptance
decisions and to help submitters better understand the types of information FDA needs to
conduct a substantive review, this guidance, including the checklists included in the
appendices, clarify the necessary elements and contents of a complete 510(k) submission.
The process we outline is applicable to all devices reviewed through the 510(k) notification
process and has been compiled into checklists for use by FDA review staff.

See Title II of the FDA Reauthorization Act of 2017 (Public Law 115-52).
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Contains Nonbinding Recommendations
It is critical to distinguish between the completeness of the regulatory submission, and the
quality of the data provided and any studies conducted in support of the submission. The
assessment of the completeness of the 510(k) occurs during the acceptance review, while the
assessment of the quality of the submitted information occurs during the substantive review.
FDA will base acceptance on the objective criteria outlined in the associated Acceptance
Checklist and not on the quality of the data.
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidance documents describe the Agency’s current thinking on a
topic and should be viewed only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word should in Agency guidance documents means
that something is suggested or recommended, but not required.

II. Background
The purpose of the 510(k) acceptance review is to assess whether a submission is
administratively complete, in that it includes all of the information necessary for FDA to
conduct a substantive review and to reach a determination regarding substantial equivalence
under section 513(i) of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 United States
Code (U.S.C.) § 360c(i)). To find a device substantially equivalent under section 513(i) of
the FD&C Act, FDA must find that it has the same intended use as the predicate device, and
either (1) has the same technological characteristics as the predicate device, or (2) has
different technological characteristics, as defined at section 513(i)(1)(B), and the submission
contains information, including appropriate clinical or scientific data if necessary, that
demonstrates the device is as safe and effective as the predicate and does not raise different
questions of safety and effectiveness than the predicate.
The 510(k) regulations at 21 CFR 807.87 to 807.100 provide greater detail regarding the
specific information that each premarket notification submission must contain. For example,
the submission must include proposed labeling (807.87(e)), a statement regarding the
similarities and differences between the device and others of comparable type (807.87(f)),
supporting data (807.87(f) and 807.100(b)(2)(ii)(B)), and FDA may request any additional
information necessary to determine whether the device is substantially equivalent when the
information provided is insufficient to enable such a determination (807.87(m)). Please also
refer to our guidance document entitled, “Format for Traditional and Abbreviated 510(k)s.” 2
Prior guidances and checklists relating to 510(k) RTA policy (i.e., 510(k) Refuse to Accept
Policy, dated June 30, 1993, and 510(k) Refuse to Accept Procedures (K94-1) blue book
memo, dated May 20, 1994) focused on defining broad issues or principles. Additionally, the
checklists associated with these guidances dealt largely with administrative elements but did
not address specific content that is essential for 510(k) review. As a result, FDA had accepted
many inadequate submissions for review, and FDA staff invested significant time in
2

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-andabbreviated-510ks.
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constructing extensive letters requesting all of the additional information needed to conduct a
substantive review. This approach was an inefficient use of resources and frequently
lengthened review times. For additional information see CDRH’s “Analysis Of Premarket
Review Times Under The 510(k) Program.” 3
The goal of the guidance titled “Refuse to Accept Policy for 510(k)s,” dated December 31,
2012 was to clarify the content needed in Traditional, Abbreviated, and Special 510(k)
submissions to allow FDA to conduct a substantive review, thereby enhancing the quality of
received 510(k) submissions and improving overall review time. The review process
presented in this document is captured in the Acceptance Checklists for Traditional,
Abbreviated, and Special 510(k) submissions, which FDA staff will use during the
acceptance review process.

III. Scope
The information presented in this document is intended to provide FDA staff with a clear,
consistent approach for acceptance review for Traditional, Abbreviated, and Special 510(k)
notifications and to outline the RTA policy on 510(k)s. It will also help submitters prepare
510(k) notifications that are administratively complete for FDA to conduct a substantive
review.
The acceptance policy does not alter the substantial equivalence decision-making process
once the submission has been accepted for review; however, it does alter the start of the FDA
review clock for purposes of MDUFA performance goals for those submissions that are not
accepted for review. More information regarding FDA’s review clock is provided in Section
V of this document.
This document does not address the monetary aspects or the MDUFA goals associated with
510(k)s. Information pertaining to the fees and payment procedures for submission of a
510(k) notification can be found in FDA’s guidance document “User Fees and Refunds for
Premarket Notification Submissions (510(k)s).” 4

IV. Q-submission Interaction
For general information regarding the 510(k) regulations under 21 CFR Part 807, submitters
should consult CDRH’s Division of Industry and Consumer Education (DICE) or CBER’s
Manufacturers Assistance and Technical Training Branch. Before submitting a 510(k)
notification, we encourage submitters, especially those who are less familiar with the 510(k)
review program or who have novel issues to address, to interact with the appropriate FDA
review staff. Such Q-submission interaction is an important way of improving the quality and
completeness of a 510(k). For additional information regarding the Q-Submission process,
3

https://www.fda.gov/media/80972/download.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-and-refundspremarket-notification-submissions-510ks.
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please refer to the guidance titled “Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program.” 5
In addition, other FDA guidance documents and resources provide valuable information for
preparing 510(k)s, including:
• “Format for Traditional and Abbreviated 510(k)s;” 6
• “The Special 510(k) Program;” 7
• “The Abbreviated 510(k) Program;” 8
• “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
[510(k)];” 9
• “eCopy Program for Medical Device Submissions;” 10
• “Types of Communication During the Review of Medical Device Submissions;” 11
• “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification
Requirements;” 12
• Other applicable device-specific and cross-cutting guidance documents; 13 and
• CDRH Device Advice. 14

V. 510(k) Refuse to Accept Policies and Procedures
FDA staff will conduct an acceptance review of all Traditional, Abbreviated, or Special
510(k)s based on objective criteria using the applicable Acceptance Checklist (see
Appendices A-C) to ensure that the 510(k) is administratively complete. In order for the
submission to be accepted, all administrative elements identified as RTA items should be
present or a rationale should be provided for those elements determined by the submitter to
be not applicable. To aid in the administrative review, it is recommended that submitters
complete and submit acceptance checklists with their submissions that identify the location
of supporting information for each RTA element.
The acceptance review, which occurs prior to the substantive review, should be conducted,
5

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetingsmedical-device-submissions-q-submission-program.
6
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-andabbreviated-510ks.
7
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-510k-program.
8
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/abbreviated-510k-program.
9
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluatingsubstantial-equivalence-premarket-notifications-510k.
10
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-devicesubmissions.
11
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/types-communication-duringreview-medical-device-submissions.
12
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/intent-exempt-certainunclassified-medical-devices-premarket-notification-requirements.
13
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidancedocuments-medical-devices-and-radiation-emitting-products.
14
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance.
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and completed within 15 calendar days of FDA receiving the 510(k) notification. An
acceptance review will only begin for 510(k) submissions for which the appropriate user fee
has been paid and a validated eCopy has been received. 15
The staff will select the applicable checklist based on the 510(k) type (i.e., Traditional,
Abbreviated, or Special). The acceptance review will be conducted on original 510(k)
submissions and responses to RTA communications, but not supplements or amendments
submitted in response to requests for additional information after a submission has been
accepted. The staff should assess whether the submission should be accepted by first
answering the preliminary questions below, and then verifying that the submission contains
all of the information identified as RTA items in the checklist.
The purpose of the 510(k) acceptance review is to assess whether a submission is
administratively complete, in that it includes all of the information necessary for FDA to
conduct a substantive review. Therefore, the submission should not be accepted and should
receive an RTA designation if one or more of the items noted as RTA items in the checklist
are not present and no explanation is provided for the omission(s). However, during the RTA
review, FDA staff has discretion to determine whether missing checklist items are needed to
ensure that the submission is administratively complete to allow the submission to be
accepted. FDA staff also has discretion to request missing checklist items interactively from
submitters during the RTA review. Interaction during the RTA review is dependent on FDA
staff’s determination that outstanding issues are appropriate for interactive review and that
adequate time is available for the submitter to provide supporting information and for FDA
staff to assess responses before the Acceptance deadline of 15 days.
If one or more items noted as RTA items on the Acceptance Checklist are not present, FDA
staff conducting the acceptance review should obtain management concurrence and notify
the designated 510(k) contact person electronically 16 that the submission has not been
accepted. 17 FDA staff should also provide the submitter with a copy of the completed
checklist indicating which item(s) are the basis for the RTA designation.
The 510(k) submitter may respond to the RTA notification by providing the missing
information identified in the checklist. The submitter should submit this information to be
included in the file under the originally assigned 510(k) number. A new submission and new
user fee are not necessary. Nor is it necessary to re-send the entire 510(k) submission, unless
FDA notes otherwise (e.g., because the majority of the submission is not in English, or the
15

For additional information, please see the guidance “FDA and Industry Actions on Premarket Notification
(510(k)) Submissions: Effect on FDA Review Clock and Goals,” available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/fda-and-industry-actions-premarket-notification-510ksubmissions-effect-fda-review-clock-and-goals.
16
For additional information about email communications with CBER, please see SOPP 8119: Use of Email for
Regulatory Communications, available at https://www.fda.gov/media/108992/download.
17
As outlined in the commitment letter for MDUFA III [158 CONG. REC. S8277-S8281 (daily ed. Corrected
December 20, 2012) (Letters from the Secretary of Health and Human Services Re: Medical Device User Fee
Program), also available at https://www.fda.gov/media/83244/download], the review clock will not start until
the 510(k) submission is accepted for review.
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submission is missing the majority of the items on the checklist). It is sufficient to submit and
address only the information requested per the Acceptance Checklist. If a response to the
RTA notification is not received within 180 days of the date of RTA notification, FDA will
consider the 510(k) to be withdrawn and the submission will be closed in the system.
Upon receipt of the newly submitted information, FDA staff should conduct the acceptance
review again following the same procedure within 15 calendar days of receipt of the new
information. The subsequent acceptance review will assess whether the new information
makes the submission complete according to the checklist criteria for completeness. If the
submission is still found to be incomplete, FDA staff should notify the contact person and
provide the new checklist indicating the missing item(s).
When a submission is accepted, FDA staff should electronically notify the submission
contact person that the 510(k) has been accepted and begin a substantive review of the
submission to determine substantial equivalence. Should FDA fail or choose not to complete
the acceptance review within the acceptance review period (i.e., within 15 calendar days of
receipt), the submitter should be electronically notified that the acceptance review was not
completed and the submission is under substantive review. FDA may request any
information that may have resulted in an RTA designation during the substantive review. 18
Once a submission has been accepted, FDA may ask for any information during the
substantive review that may have been unintentionally overlooked during the acceptance
review.
FDA Review Clock
As explained in the commitment letter for MDUFA IV referenced in Title II of the FDA
Reauthorization Act of 2017 (Public Law 115-52), “FDA days begin on the date of receipt of
the submission or of the amendment to the submission that enables the submission to be
accepted (510(k)) or filed (PMA).” 19 Thus, the FDA review clock does not start when a
submission is placed on eCopy or User Fee hold or designated RTA.
510(k) submissions and additional information submitted in response to a RTA designation
are received by the respective Center’s Document Control Center (DCC). The FDA review
clock start date is the DCC receipt date of the most recent submission or additional
information that resulted in an acceptance designation for the 510(k), provided the submission
user fee has been paid and a validated eCopy has been provided. For example, if the
submission is accepted for substantive review on the first acceptance review, the FDA review
clock start date is the DCC receipt date of the submission. However, if the submission is
designated RTA, the FDA review clock start date is not yet known. In such cases, the clock
18

In the case of a government closure during the 15-day review period, the review period may be extended by a
comparable number of business days that the FDA buildings are closed. If the submitter receives an automated
notice that the acceptance review was not completed because the screening period has exceeded 15 days, FDA
may send a correction notice to the submitter.
19
See 163 CONG. REC. S4729-S4736 (daily ed. August 2, 2017) (Food and Drug Administration User Fee
Reauthorization), also available at https://www.fda.gov/media/102699/download.
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Contains Nonbinding Recommendations
start date will be the DCC receipt date of the submission including the additional information
that results in an acceptance designation (even if FDA later requests information that should
have been requested during acceptance review). In the event the acceptance review was not
completed within 15 calendar days, the submission will be considered to be under substantive
review, and the FDA review clock start date will be the DCC receipt date of the most
recently received information for the submission. Once the submission is under substantive
review the calendar days used to conduct the acceptance review (i.e., up to 15 days) are
included within the 60 calendar days to reach the Substantive Interaction goal as described in
the aforementioned commitment letter for MDUFA IV.
Notification of Acceptance Review Result
The submitter should receive an electronic notification of the acceptance review result within
15 calendar days of DCC receipt (i.e., that the submission has been accepted for substantive
review, that the submission is not accepted for review (RTA), or that the submission is now
under substantive review because the acceptance review was not completed). The notification
will be sent only to the designated contact person identified in the submission. This
notification will also serve to identify the FDA 510(k) lead reviewer 20 assigned to the
submission. The notification of either the acceptance or RTA designation will be made only
with supervisory concurrence of the reviewer’s acceptance review determination. The
notification of acceptance or RTA designation may occur on any day prior to the 15th
calendar day of DCC receipt. However, in the event the acceptance review was not
conducted, a notification that an RTA review was not conducted will be sent on the 16th day.
In the case of RTA designation, the notification should be accompanied by the completed
checklist indicating the missing elements that resulted in the RTA designation. The
completed checklists are considered part of the submission’s administrative file and will not
be posted publicly. Therefore, it is imperative that the submission identify complete contact
information, including the email address to which the notification should be sent. 21

VI. Refuse to Accept Principles
In order to use this guidance appropriately, FDA staff should review the following basic
principles regarding FDA’s review policies and procedures.
Acceptance should not be based on a substantive review of the information provided in the
510(k) notification.
It is important to make the distinction between the acceptance review and the substantive
review. The acceptance review is conducted to assess whether the submission contains all of
the appropriate elements, as identified in the applicable checklist, in order to begin a
substantive review. In assessing whether a 510(k) notification should be accepted, submitted
20

In the case of 510(k)s submitted to CBER, whenever the term lead reviewer is used in this guidance, the
equivalent CBER contact person is the regulatory project manager (RPM).
21
CBER will accommodate the use of faxes; submitters may also wish to provide a fax number.
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information is not evaluated for adequacy to support a finding of substantial equivalence. The
checklist is a tool to ensure that the submission contains the necessary information in order to
conduct a substantive review (i.e., FDA should not refuse to accept a submission if
information is present but inadequate to support a finding of substantial equivalence). The
evaluation of the quality of the content and the substantial equivalence decision making
process occur within the substantive review once the file has been accepted.
FDA staff should determine whether the submitter provided a justification for any alternative
approach.
The submitter may provide a rationale for why any criteria in the checklist are not applicable
to the device. Likewise, the submitter may provide a rationale for any deviation from a
device- specific or cross-cutting guidance document or FDA-recognized standard. It is
FDA’s expectation that each item in the checklist will be addressed either by including the
requested information or providing a rationale for why it is not applicable or why there is a
deviation.
FDA will not consider a given criterion in the checklist to be “Present” if the submission fails
to include either the information requested or a rationale for omission or deviation. If a
justification to omit certain information or for taking an alternative approach is provided,
FDA will consider the adequacy of that justification or alternative approach during
substantive review of the submission. See Acceptance Review section below for examples
and further explanation.
Device-specific and cross-cutting guidance documents, applicable recognized standards, and
applicable regulations will be considered when making an RTA determination.
Before submitting a 510(k), the submitter should consider the currently available guidance
documents and standards, as well as applicable regulations for the proposed device in the
preparation of the submission. FDA staff and industry are encouraged to refer to the product
classification database 22 to assist in identifying any applicable recognized consensus
standards. If citing voluntary consensus standards, the submitter should consider FDA’s
guidance “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for
Medical Devices.” 23
Specifically, the checklist includes questions regarding whether the submission has addressed
recommendations regarding the device description, labeling, and performance testing as
outlined in a device-specific guidance, special controls or another specific regulation. Note
that “addressed” means that the submission includes information pertinent to those
recommendations or requirements; assessment of the adequacy of that information in
meeting those recommendations or requirements should be assessed during review.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntaryconsensus-standards-premarket-submissions-medical-devices.
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If there is a device-specific guidance, other than a special controls guidance document, the
submission includes information to establish that the submitter has addressed the
recommendations or otherwise provided an alternative approach intended to address the
applicable statutory and/or regulatory criteria.
If there are special controls applicable to the device, the submission includes information
addressing the particular mitigation measures set forth in the special controls, or uses
alternative mitigation measures and provides a rationale to demonstrate that those alternative
measures identified by the submitter will provide at least an equivalent assurance of safety
and effectiveness.

VII. The Checklist – Preliminary Questions
Within 15 calendar days of receipt of the 510(k), FDA staff should answer the preliminary
questions below, which are included on the first page of the Acceptance Checklists for
Traditional and Abbreviated 510(k)s. The preliminary questions are intended to be answered
by the 510(k) lead reviewer as an initial screening of the submission. FDA does not intend
for the submitter to have addressed these items in their submission. Depending upon the
answers to these preliminary questions, the remainder of the acceptance review may or may
not be necessary.
If the responses to the preliminary questions and subsequent consultation with the Center
personnel identified below indicate that the 510(k) acceptance review should not continue 24
the 510(k) lead reviewer should promptly:
• inform the 510(k) review team (including consulting reviewers); and
• notify the submitter using proper administrative procedures.
The preliminary questions are:
1. Is the product a device (per section 201(h) of the FD&C Act) or a combination
product (per 21 CFR 3.2(e)) with a device constituent part subject to review in a
510(k)?
If the product does not appear to meet the definition of a device under section 201(h) of
the FD&C Act, or does not appear to be a combination product with a device constituent
part, then the 510(k) lead reviewer should consult with the CDRH Product Jurisdiction
Officer or the CBER Product Jurisdiction Officer to determine the appropriate action, and
inform management. If FDA staff determines that the product is not a device and is not a
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FDA will not process a 510(k) unless it meets the following requirements: i) the submission must be sent
with the user fee required by section 738 of the FD&C Act, and ii) the firm must submit the correct number of
copies per 21 CFR 807.90(c). FDA has issued guidance to implement section 1136 of FDASIA, which added
section 745A(b) of the FDA&C Act (“eCopy Program for Medical Device Submissions,” available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-devicesubmissions). Since any 510(k) not meeting these two requirements will not be processed by the respective
Center’s DCC, they are not included in the checklist.
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combination product with a device constituent part, the 510(k) lead reviewer should stop
the review and notify the submitter.
2. Is the submission with the appropriate Center?
If the submission is for a single-entity device and appears to be subject to review in a
Center different from the one to which it was submitted, or if it is for a combination
product with a device constituent part and it appears that a Center different from the one
to which it was submitted has the lead, the 510(k) lead reviewer should consult with the
CDRH Product Jurisdiction Officer or the CBER Product Jurisdiction Officer to
determine the appropriate action and inform management. If the 510(k) is submitted to
CDRH and CDRH staff determines that the submission is not subject to CDRH review,
or the 510(k) is submitted to CBER and CBER staff determines that the submission is not
subject to CBER review, the 510(k) review team should stop the review and notify the
submitter.
3. If a Request for Designation (RFD) was submitted for the device or combination
product with a device constituent part and assigned to your center, identify the RFD
# and confirm the following:
(a) Is the device or combination product the same (e.g., design, formulation) as
that presented in the RFD submission?
(b) Are the indications for use for the device or combination product identified
in the 510(k) the same as those identified in the RFD submission?
An RFD determination is specific to the device or combination product and indications
for use for the device or combination product described in the RFD submission. If the
device or combination product has been modified or the indications for use have been
modified since the RFD, the RFD determination may no longer be applicable and
jurisdiction may need to be reevaluated by the Office of Combination Products (OCP).
The 510(k) lead reviewer should consult with the CDRH Product Jurisdiction Officer or
the CBER Product Jurisdiction Officer to determine the appropriate action and inform
management.
4. Is the submission for a combination product that contains as a constituent part a
drug that has the same active moiety as an approved drug with exclusivity as
described in 21 USC 503(g)(5)(C)(ii)-(v) (section 503(g)(5)(C)(ii)-(v) of the FD&C
Act)?
If the submission is for a combination product and contains as a constituent a drug that
has the same active moiety as an approved drug with exclusivity as described in 21 USC
503(g)(5)(C)(ii)-(v), the 510(k) lead reviewer should contact the CDRH Product
Jurisdictional Officer or CBER Product Jurisdiction Officer to determine the appropriate
action and inform management.
5. Is this device type eligible for a 510(k) submission?
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FDA staff should determine whether the 510(k) submission is for a device type for which
510(k) is known to be an inappropriate regulatory approach, such as when the device type
is Class III type and a PMA is required, or the device type is Class I or II and 510(k)exempt. If a 510(k) is not appropriate, FDA staff should make this determination during
the acceptance review and notify the submitter of the determination. This preliminary
question is not intended to identify submissions for which a substantive review is
required in order to determine if 510(k) is an inappropriate approach (e.g., device has a
new intended use or device has different technological characteristics that raise different
questions of safety and effectiveness).
6. Is there a pending PMA for the same device with the same indications for use?
If the submitter has a PMA for the same device with the same indications for use
pending, the review team should stop the review. The 510(k) review team should consult
management and other Center resources to determine which premarket review pathway
applies to the device and the appropriate processes for addressing the situation. FDA staff
should also consult management and other Center resources if a 510(k) and PMA have
been submitted for the same device type by different submitters.
7. If clinical studies have been submitted, is the submitter the subject of the
Application Integrity Policy (AIP)? 25
The 510(k) lead reviewer should refer to the AIP list. 26 If the submitter is on the list, the
reviewer should consult the CDRH Office of Product Evaluation and Quality/Office of
Clinical Evidence and Analysis/Division of Clinical Science and Quality
(OPEQ/OCEA/DCEA1) or CBER Office of Compliance and Biologics Quality/Division
of Inspections and Surveillance/ Bioresearch Monitoring Branch (OCBQ/DIS/BMB) to
determine the appropriate action.

VIII. The Checklists – Acceptance Review
Organizational Elements
Although missing one or more of the items in the table of Organizational Elements in the
Acceptance Checklists, such as a Table of Contents or page numbers, generally will not lead
to an RTA decision, we strongly encourage submitters to incorporate these elements in their
submissions to facilitate FDA review and decision-making. If, however, the submission is so
disorganized that FDA cannot locate the information needed to assess substantial
25

When data in a pending submission have been called into question by certain wrongful acts (fraud, untrue
statements of material facts, bribery, or illegal gratuities), FDA intends to defer substantive scientific review of
such data until completion of a validity assessment and questions regarding reliability of the data are resolved.
(See FDA Guide 7150.09 Compliance Policy Guide, Chapter 50 – General Policy – Subject: Fraud, Untrue
Statements of Material Facts, Bribery, and Illegal Gratuities, 56 FR 46191).
26
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/application-integritypolicy/application-integrity-policy-list.
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Contains Nonbinding Recommendations
equivalence, or if the submission is so poorly written (e.g., in broken English) that the
information submitted to support substantial equivalence cannot be understood, the
submission should receive an RTA decision.
Elements of a Complete Submission (RTA Items)
The objective criteria in these checklists outline those elements that are explicitly required by
regulation or that are essential to FDA’s substantive review of the submission and
determination of substantial equivalence under section 513(i) of the FD&C Act. For example,
proposed labels, labeling, and instructions are required by 21 CFR 807.87(e)), while a
description of the materials, design, and other features of the device is essential to
determining whether its technological characteristics are the same as those of the predicate
and whether any differences raise different questions of safety and effectiveness under
section 513(i) of the FD&C Act.
We have also identified several categories and subcategories of data and information that,
when applicable, are critical to supporting a statement indicating the device is similar to
and/or different from other products of comparable type under 21 CFR 807.87(f) and the
substantial equivalence determination. For example, if the new device has direct or indirect
tissue-contacting components, a biocompatibility assessment will be essential to evaluating
whether the new device is as safe as the predicate with respect to the risk of toxicity it poses
to the patient. While testing and data would usually be necessary for such an assessment, this
is not always the case (for example if the device under review and the predicate are identical
in all relevant respects), and acceptance should be based only on the presence of an item or
an explanation why the item is not applicable, not the adequacy of such explanation. If the
device has no direct or indirect tissue-contacting components, no biocompatibility
assessment would be necessary and the biocompatibility items on the checklist would be not
applicable.
Because the applicability of these categories is also critical to the substantial equivalence
determination, in order to be accepted, all submissions should include a statement indicating
whether these categories apply, as outlined in the Acceptance Checklist (e.g., materials,
presence of software, whether the device is intended to be used sterile). When performance
data are provided, the submission of full test reports describing how the testing was
conducted is crucial to FDA’s assessment of whether the data support a finding of substantial
equivalence.
Where a device-specific guidance document exists for the subject device, the submitter
should follow the recommendations included in that document, or the submitter should
provide a rationale for addressing the scientific issues discussed in the guidance document
using an alternative approach intended to address the applicable statutory and/or regulatory
criteria. In the absence of the recommended information and without a rationale for an
alternative approach, the submission should be considered incomplete and not accepted. If
special controls have been identified, those controls should be addressed in order for the
submission to be accepted, or alternative mitigation measures providing a rationale to
demonstrate that those alternative measures will provide at least an equivalent assurance of
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safety and effectiveness should be identified.
Applying the Checklist of RTA Items
Using the Acceptance Checklist appropriate to the submission type (traditional, abbreviated,
or special), within 15 calendar days of receipt of the 510(k), FDA staff should answer each
question for the elements identified as RTA items. For those items that have an option of
“yes,” “no,” or “not applicable (N/A)” as an answer, the item should receive an answer of
“yes” or “N/A” for the 510(k) submission to be accepted for substantive review.
For the first question in each section related to the need for certain performance data (such as
biocompatibility, sterilization, software), FDA staff should indicate whether the submission
has addressed one of the options for the 510(k) submission to be accepted for substantive
review. For example, the submission should state explicitly that either there are or are not
direct or indirect (e.g., through fluid infusion) tissue-contacting components in order for the
submission to be considered complete and accepted for substantive review.
Elements Marked “Not applicable”
In developing the checklists, the Agency has considered the general categories and respective
subcategories of information that are necessary to conduct a substantive review for the wide
range of medical devices that are appropriate for review under 510(k). All such criteria may
not be pertinent to a particular device. FDA staff should select “N/A” for those elements that
do not apply to the subject device. For example, the requirements for financial certification
and disclosure statements (21 CFR 807.87(i)) and statements of compliance for clinical
investigations (21 CFR 807.87(j)) only apply to submissions with clinical data. If the
submission contains no clinical data, FDA staff should select “N/A.”
Adequacy of information
In order to make the checklist criteria objective, for each RTA item, FDA should consider
only the presence or omission of the element or a rationale for the omission of the element or
use of an alternative approach during acceptance review. It is likely that FDA staff will
encounter scenarios where information is provided, but is incomplete or inadequate. In such
instances, FDA staff should answer the question for the respective item as “Yes,” but may
communicate the inadequacy or request additional information in the course of the
substantive review. For example, the submitter may have provided full test reports for all
performance testing; however, during the acceptance review, the reviewer may note that the
results of a particular test may not be sufficient to support a finding of substantial
equivalence and additional justification would be needed. The performance testing criterion
would be marked “Yes” in the checklist, and the full assessment of the results and
communication to the submitter that additional justification is needed should occur during the
substantive review.
During RTA review, issues may be identified that do not determine the acceptability of a
submission, but are issues that should be resolved prior to a final decision. This does not
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mean that a complete review of the submission has been conducted. These identified issues
are referred to as “observations.” If observations are identified, they will be attached to the
RTA checklist that is sent to the official contact. This attachment is called an Addendum.
You do not need to provide a response to the observation(s) in your RTA response in order
for your file to be considered administratively complete and accepted for substantive review;
however, addressing these questions could help to facilitate the substantive review of your
submission.
Elements Marked “No”
For any acceptance criterion designated as “No,” FDA intends to provide an explanation to
describe the missing element(s), if needed. This explanation is particularly important for a
criterion in which it may not be immediately apparent to the submitter what necessary
information, specifically, is not present. For example, the Device Description section
includes an element that states, “submission addresses device description recommendations
outlined in the device- specific guidance document” and a notation of “No” alone may not be
sufficient to inform the submitter of what specific piece(s) of information is missing. FDA
staff should include a list or statement of the additional information that is necessary to meet
the acceptance criteria. This list or statement can be communicated in the “comment” section
on the checklist beside each specific criterion.
Prior Submissions Relevant to the Submission Under Review
For certain submissions, the submitter may have made prior submissions for the same device
for which FDA provided feedback related to the data or information needed to support
substantial equivalence (e.g., a Q-Submission, investigational device exemption (IDE)
application, prior NSE determination, prior 510(k) that was deleted or withdrawn). When
such prior feedback is relevant to determining whether substantial equivalence of the subject
device exists, the new submission should include information to address this prior feedback
and the checklists should include criteria related to this issue. To address the criterion
regarding whether a prior submission (or no prior submission) exists, FDA recommends that
submitters provide this information in Section F (prior related submissions section) of the
CDRH Premarket Review Submission Cover Sheet form (Form 3514). 27 Submitters should
list prior submission numbers in Section F of this form or state that there were no prior
submissions to address this criterion. Please be advised that leaving this section of the form
blank will not be considered a statement that there were no prior submissions. This
information may also be included in the Cover Letter (i.e., as a statement that there were no
prior submissions for the device or a listing of the numbers(s) of the prior submission(s)).
Where one or more prior submissions do exist, FDA suggests designating a separate section
of the submission that identifies the prior submission(s) by number, includes a copy of the
FDA feedback (e.g., letter, meeting minutes), and states how or where in the submission this
prior feedback was addressed. Note that the adequacy of how the feedback was addressed
should be assessed during the substantive review.
27

https://www.fda.gov/media/72421/download.
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Combination Product Administrative Items
The 21st Century Cures Act, which amended section 503(g) of the FD&C Act, requires
submitters seeking action on a combination product to identify the product as such [§
503(g)(8)(C)(v)]. Additionally, per the amended section 503(g)(5), submissions for deviceled, device-drug combination products must include the patent certification or statement as
described in section 505(b)(2) and provide notice as described in section 505(b)(3) if the
combination product contains as a constituent part an approved drug. See section
503(g)(5)(A). Submitters of products that are not combination products, as defined in 21
CFR 3.2(e), should mark “N/A” and omit this section pertaining to combination products.
Submitters of Combination Products That Do Not Contain as a Constituent Part an
Approved Drug
If the combination products do not include as a constituent part an approved drug as defined
in section 503(g)(5)(B), submitters of device-led, device-drug combination products should
mark “N/A” for question 10 (question 9 in the Special RTA Checklist).
Submitters of Combination Products That Contain as a Constituent Part an Approved Drug
Submitters of combination products containing as a constituent part an approved drug should
address question 11 (question 10 in the Special RTA Checklist) by including patent
information. For each relevant patent, the submitter should include certification to one of the
following certifications:
i.
That such patent information has not been filed (505(b)(2)(A)(i)).
ii.
That such patent has expired (505(b)(2)(A)(ii)).
iii. The date on which the patent will expire (505(b)(2)(A)(iii)).
iv.
That such patent is invalid or will not be infringed by the manufacture, use, or sale of
the drug constituent part for which this submission is made (505(b)(2)(A)(iv)).
However, for a method of use patent which does not claim a use for which the submitter is
seeking approval, the submitter should include a statement per section 505(b)(2)(B) that the
method of use patent does not claim such a use.
Submitters including a certification under paragraph iv (505(b)(2)(A)(iv)) should also certify
that they will provide notice to the owner of the patent(s) and the holder of the approved
application that lists the patent(s) that is/are being challenged. The process for giving notice
is provided in section 505(b)(3) of the FD&C Act. Submitters should submit to FDA
documentation of the date of receipt of notice by holder of the approved application and
patent(s) owner.
Conversion of Special 510(k) to Traditional 510(k)
FDA has developed separate checklists to address the differences in content for Special and
Traditional 510(k) submissions. FDA staff will utilize the appropriate checklist based on the
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Contains Nonbinding Recommendations
file type as designated by the submitter. In the event that the submitter has submitted a
Special 510(k), but FDA determines that the file should be converted to a Traditional
510(k) 28 FDA will notify the contact person designated in the 510(k) submission of the
conversion and the rationale for the conversion. If the file is converted from a Special to a
Traditional within the 15 calendar day acceptance review period, the Traditional 510(k)
Acceptance Checklist will be used to conduct the acceptance review and the review clock
start date will be assigned as outlined in the 510(k) Refuse to Accept Policies and Procedures
section above. Given the differences in content for Special and Traditional 510(k)s, it is
likely that the converted submission will result in an RTA designation using the Traditional
Acceptance Checklist. FDA staff should provide the completed Acceptance Checklist for
Traditional submissions indicating which elements are missing. The submitter may respond
by providing the identified information and the subsequent acceptance review will proceed
with the Traditional checklist. If the file is converted from a Special to a Traditional after the
15 calendar day acceptance review period, any missing information that would have resulted
in RTA designation should be obtained during the substantive review.

Please see “Special 510(k) Factors,” items 1-4 of the Acceptance Checklist for Special 510(k)s for potential
reasons for conversion.
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Appendix A. Acceptance Checklist for Traditional
510(k)s
(Should be completed within 15 days of DCC receipt)
The following information is not intended to serve as a comprehensive review.
FDA recommends that the submitter include this completed checklist as part of the application.
510(k)#:

Date Received by DCC:

510(k) Lead Reviewer:
Center:

Office:

Division:

Decision: Accept_____ Refuse to Accept_____
If Accept, notify the submitter.
If Refuse to Accept, notify submitter electronically and include a copy of this checklist.
Is an Addendum attached?: Yes No
Note: If an element is left blank on the checklist, it does not mean the checklist is incomplete;
it means the reviewer did not assess the element during the RTA review and that the element
will be assessed during substantive review.

Preliminary Questions
Answers in the shaded blocks indicate consultation with an identified Center
advisor is needed. (Boxes checked in this section represent FDA’s preliminary
assessment of these questions at the time of administrative review.)
1.

Yes

Is the product a device (per section 201(h) of the FD&C Act) or a
combination product (per 21 CFR 3.2(e)) with a device constituent part
subject to review in a 510(k)?
If it appears not to be a device (per section 201(h) of the FD&C Act) or such a
combination product (per 21 CFR 3.2(e)), or you are unsure, consult with the
CDRH Product Jurisdiction Officer or the CBER Product Jurisdiction Officer to
determine the appropriate action, and inform management. Provide a summary of
the Product Jurisdiction Officer’s determination/recommendation/action in the
comment section below.
If the product does not appear to be a device or such a combination product, mark
21

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Contains Nonbinding Recommendations
“No.”
Comments:
2.

Is the submission with the appropriate Center?
If the product is a device or a combination product with a device constituent part,
is it subject to review by the Center in which the submission was received? If you
believe the submission is not with the appropriate Center or you are unsure,
consult with the CDRH Product Jurisdiction Officer or the CBER Product
Jurisdiction Officer to determine the appropriate action and inform your
management. Provide a summary of the Product Jurisdiction Officer’s
determination/recommendation/action in the comment section below.
If submission should not be reviewed by your Center mark “No.”

Comments:
3.

If a Request for Designation (RFD) was submitted for the device or
combination product with a device constituent part and assigned to your
center, identify the RFD # and confirm the following:
(a) Is the device or combination product the same (e.g., design,
formulation) as that presented in the RFD submission?
(b) Are the indications for use for the device or combination product
identified in the 510(k) the same as those identified in the RFD
submission?
If you believe the product or the indications presented in the 510(k) have changed
from the RFD, or you are unsure, consult with the CDRH Product Jurisdiction
Officer or the CBER Product Jurisdiction Officer to determine the appropriate
action and inform your management. Provide a summary of Product Jurisdiction
Officer’s determination/recommendation/action in the comment section below.
If the answer to either question above is no, mark “No.” If there was no RFD,
mark “N/A.”

Comments:
4.

Is the submission for a combination product that contains as a constituent
part a drug that has the same active moiety as an approved drug with
exclusivity as described in 21 USC 503(g)(5)(C)(ii)-(v) (section
503(g)(5)(C)(ii)-(v) of the FD&C Act)?
If “Yes,” then contact the CDRH Product Jurisdiction Officer or CBER Product
Jurisdiction Officer to determine the appropriate action and inform your
management. Provide the summary of the Product Jurisdiction Officer’s
determination/recommendation/action in the comment section below.

Comments:
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Contains Nonbinding Recommendations
5.

Is this device type eligible for a 510(k) submission?
If a 510(k) does not appear to be appropriate (e.g., Class III type and PMA
required, or Class I or II type and 510(k)-exempt), consult with the appropriate
CDRH or CBER staff during the acceptance review, provide a summary of the
discussion with them, and indicate their recommendation/action in the comment
section below. If 510(k) is not the appropriate regulatory submission, mark “No.”

Comments:
6.

Is there a pending PMA for the same device with the same indications for
use?
If “Yes,” consult your management and CDRH Office of Product Evaluation and
Quality/Office of Regulatory Programs/Division of Regulatory Programs 1
(Submission Support) (OPEQ/ORP/DRP1) or appropriate CBER staff to
determine the appropriate action.

Comments:
7.

If clinical studies have been submitted, is the submitter the subject of an
Application Integrity Policy (AIP)?
If “Yes,” consult with the CDRH Office of Product Evaluation and
Quality/Office of Clinical Evidence and Analysis/Division of Clinical Science
and Quality (OPEQ/OCEA/DCEA1) or CBER Office of Compliance and
Biologics Quality/Division of Inspections and Surveillance/Bioresearch
Monitoring Branch (OCBQ/DIS/BMB) to determine the appropriate action,
provide a summary of the discussion with them, and indicate their
recommendation/action.
If no clinical studies have been submitted, mark “N/A.” Check on the AIP list at
https://www.fda.gov/inspections-compliance-enforcement-and-criminalinvestigations/application-integrity-policy/application-integrity-policy-list.

Comments:
• If the answer to 1 or 2 appears to be “No,” then stop review of the 510(k) and contact the
CDRH Product Jurisdiction Officer or CBER Product Jurisdiction Officer.
• If the answer to 3a or 3b appears to be “No,” then stop the review and contact the CDRH
Product Jurisdiction Officer or CBER Product Jurisdiction Officer.
• If the answer to 4 is “Yes,” then contact the CDRH Product Jurisdiction Officer or CBER
Product Jurisdiction Officer, provide a summary of the discussion with them, and indicate
their recommendation/action.
• If the answer to 5 is “No”, the lead reviewer should consult division management and other
Center resources to determine the appropriate action.
• If the answer to 6 is “Yes,” then stop review of the 510(k), contact CDRH/OPEQ/ORP/DRP1,
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Contains Nonbinding Recommendations
or appropriate CBER staff.
• If the answer to 7 is “Yes,” then contact CDRH/OPEQ/OCEA/DCEA1 or
CBER/OCBQ/DIS/BMB, provide a summary of the discussion with DCEA1 or BMB Staff,
and indicate their recommendation/action.

Organizational Elements
Failure to include these items should not result in an RTA designation.
*Submitters including the checklist with their submission should identify the
page numbers where requested information is located. Use the comments
section for an element if additional space is needed to identify the location of
supporting information.
1.

Submission contains a Table of Contents.

Each section is labeled (e.g., headings or tabs designating Device Description
section, Labeling section, etc.).

All pages of the submission are numbered.
All pages should be numbered in such a manner that information can be
referenced by page number. This may be done either by consecutively
numbering the entire submission, or numbering the pages within a section
(e.g., 12-1, 12-2…).

Yes

*Page #

Type of 510(k) is identified (i.e., Traditional, Abbreviated, or Special)
If type of 510(k) is not designated, review as a Traditional 510(k).
Comments:

Elements of a Complete Submission (RTA Items)
(21 CFR 807.87 unless otherwise indicated)
Submission should be designated RTA if not addressed.
•

•

Any “No” answer will result in a “Refuse to Accept” decision; however, FDA staff has discretion to
determine whether missing items are needed to ensure that the submission is administratively
complete to allow the submission to be accepted or to request missing checklist items interactively
from submitters during the RTA review.
Each element on the checklist should be addressed within the submission. The submitter may
provide a rationale for omission for any criteria that are deemed not applicable. If a rationale is
provided, the criterion is considered present (Yes). An assessment of the rationale will be considered
during the review of the submission.

Yes

N/A

*Page #

All content used to support the submission is written in English
(including translations of test reports, literature articles, etc.).
Comments:

Submission identifies the following (FDA recommends use of
the CDRH Premarket Review Submission Cover Sheet form
(Form 3514, available at
https://www.fda.gov/media/72421/download)):
a.

Device trade/proprietary name

Device class and panel OR
Classification regulation OR
Statement that device has not been classified with rationale
for that conclusion

Comments:
3.

Submission contains an Indications for Use Statement with Rx
and/or OTC designated (see also 21 CFR 801.109, and FDA’s
guidance “Alternative to Certain Prescription Devices Labeling
Requirements,” available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/alternative-certainprescription-device-labeling-requirements.)
See recommended format
(https://www.fda.gov/media/86323/download).
Comments:

Submission contains a 510(k) Summary or 510(k) Statement.
Refer to 21 CFR 807.92 and 21 CFR 807.93 for contents of
510(k) Summary and Statement, respectively. Adequacy of the
content will be assessed during substantive review.
Comments:

Yes

N/A

*Page #

Comments:
6.

Submission is a Class III 510(k) Device.
Select “N/A” only if submission is not a Class III 510(k).
a.

Contains Class III Summary and Certification per 21 CFR
807.87(k).
See recommended content (https://www.fda.gov/medicaldevices/premarket-notification-510k/premarketnotification-class-iii-certification-and-summary). Select
“N/A” only if submission is not a Class III 510(k).

Comments:
7.

Submission contains clinical data.
Select “N/A” if the submission does not contain clinical data. If
“N/A” is selected, parts a, b, and c below are omitted from the
checklist.
a.

Submission includes completed Financial Certification
(FDA Form 3454, available at
https://www.fda.gov/media/70465/download) or Disclosure
(FDA Form 3455, available at
https://www.fda.gov/media/69872/download) information
for each covered clinical study included in the submission.
Select “N/A” if the submitted clinical data is not a
“covered clinical study” as defined in the guidance entitled
“Financial Disclosures by Clinical Investigators,”
available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/financialdisclosure-clinical-investigators.

Yes

N/A

*Page #

For multicenter clinical investigations involving both
United States (US) and outside United States (OUS) sites,
part (i) should be addressed for the US sites and part (ii)
should be addressed for the OUS sites. 21 CFR 812.28
applies to all OUS clinical investigations that enroll the
first subject on or after February 21, 2019.
Please refer to the guidance document entitled
“Acceptance of Clinical Data to Support Medical Device
Applications and Submissions - Frequently Asked
Questions,” available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/acceptanceclinical-data-support-medical-device-applications-andsubmissions-frequently-asked for more information.
i.
For each clinical investigation conducted in the US,
the submission includes a statement of compliance
with 21 CFR parts 50, 56, and 812.
OR
The submission includes a brief statement of the
reason for noncompliance with 21 CFR parts 50, 56,
and 812.
Select “N/A” if the clinical investigations were
conducted solely OUS.
27

Yes

N/A

*Page #

Comments:

The submission identifies prior submissions for the same device
included in the current submission (e.g., submission numbers for
a prior not substantially equivalent [NSE] determination, prior
deleted or withdrawn 510(k), Q-Submission, IDE, PMA, etc.).
OR
States that there were no prior submissions for the subject
device.
Prior submissions (or no prior submissions) for this device
should be included in Section F (prior related submissions) of
the CDRH Premarket Review Submission Cover Sheet form
(Form 3514, available at
https://www.fda.gov/media/72421/download). This information
may also be included in the Cover Letter (i.e., as a statement that
there were no prior submissions for the device or a listing of the
number(s) of the prior submissions).

Yes

N/A

*Page #

Comments:
9.

The submission utilizes voluntary consensus standard(s) (See
section 514(c) of the FD&C Act). This includes both FDArecognized and non-recognized consensus standards. Select
“N/A” if the submission does not utilize voluntary consensus
standards.
a.

The submission cites FDA-recognized voluntary consensus
standard(s).

Yes

N/A

*Page #

The submission cites non-FDA-recognized voluntary
consensus standard(s).
i.
The basis of use is included along with the underlying
information or data that supports how the standard
was used.
Comments:
Combination Product Provisions – Per 503(g) of the FD&C Act.
Select “N/A” if the product is not a combination product. 21 CFR
3.2(e). The remaining criteria in this section will be omitted from the
checklist if "N/A" is selected. If you are unsure if the product is a
combination product, consult with the CDRH Product Jurisdiction
Officer or CBER Product Jurisdiction Officer.
10.

Submission identifies the product as a combination product.

11.

The combination product contains as a constituent part an
approved drug as defined in section 503(g)(5)(B) of the FD&C
Act. Select “N/A” if the combination product does not contain as
a constituent part an approved drug. Please also select “N/A” if a
right of reference or use for the drug constituent part(s) is
included with the submission. If “N/A” is selected, part a below
is omitted from the checklist.
30

Yes

N/A

*Page #

Comments:
B.

Device Description
12.

The device has a device-specific guidance document, special
controls, and/or requirements in a device-specific classification
regulation regarding the device description that is applicable to
the subject device.
If “N/A” is selected, parts a and b below are omitted from the
checklist.
a.

The submission addresses device description
recommendations outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended
to address the applicable statutory and/or regulatory
criteria.
Select “N/A” if there is no applicable device-specific
guidance. Select “No” if the submission does not include a
rationale for any omitted information or any alternative
approach as outlined above. Note that the adequacy of
how recommendations in a device-specific guidance, etc.,
have been addressed should be assessed during the
substantive review.

Yes

N/A

*Page #

Comments:
13.

Descriptive information is present and consistent within the
submission (e.g., the device description section is consistent with
the device description in the labeling).
Comments:

14.

The submission includes descriptive information for the device,
including the following:
a.

A description of the principle of operation or mechanism of
action for achieving the intended effect.

A description of proposed conditions of use, such as
surgical technique for implants; anatomical location of use;
user interface; how the device interacts with other devices;
and/or how the device interacts with the patient.

A list and description of each device for which clearance is
requested.
Select “N/A” if there is only one device or model.
“Device” may refer to models, part numbers, various sizes,
etc.

Yes

N/A

*Page #

Comments:
15.

Device is intended to be marketed with accessories and/or as part
of a system.
Select “N/A” if the device is not intended to be marketed with
accessories and/or as part of a system. If “N/A” is selected,
parts a-c below are omitted from the checklist.
a.

Submission includes a list of all accessories to be marketed
with the subject device.

Submission includes a description (as detailed in item
14a., 14b., and 14d. above) of each accessory.
Select “N/A” if the accessory(ies) has been previously
cleared, or is exempt, and the proposed indications for use
are consistent with the cleared indications.

A 510(k) number is provided for each accessory that
received a prior 510(k) clearance.
AND
A statement is provided that identifies accessories that have
not received prior 510(k) clearance.
Comments:
33

Yes

N/A

*Page #

Submitter has identified a predicate device(s), including the
following information:
a.

Predicate device identifier provided (e.g., 510(k) number,
De Novo number, reclassified PMA number, classification
regulation reference, if exempt (e.g., 21 CFR 872.3710), or
statement that the predicate is a preamendment device).
For predicates that are preamendments devices,
information is provided to document preamendments
status.
Information regarding documenting preamendment status
is available online (https://www.fda.gov/medicaldevices/quality-and-compliance-medicaldevices/preamendment-status).

The identified predicate(s) is consistent throughout the
submission (e.g., the predicate(s) identified in the
Substantial Equivalence section is the same as that listed in
the 510(k) Summary (if applicable) and that used in
comparative performance testing.
Comments:

17.

Submission includes a comparison of the following for the
predicate(s) and subject device and a discussion why any
differences between the subject and predicate(s) do not impact
safety and effectiveness [see section 513(i)(1)(A) of the FD&C
Act and 21 CFR 807.87(f)].
See the FDA guidance document “The 510(k) Program:
Evaluating Substantial Equivalence in Premarket Notifications
[510(k)],” available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/510k-programevaluating-substantial-equivalence-premarket-notifications-510k
for more information on comparing intended use and
technological characteristics.

Yes

N/A

*Page #

Technology, including technical specifications, features,
materials, and principles of operation
Examples of technological characteristics include, but are
not limited to design, features, materials, energy source,
and principle of operation.
FDA recommends a tabular format for comparing
technological characteristics. Any characteristic that is the
same as the predicate(s) should be explicitly stated.
Differences in technological characteristics should be
identified and a rationale provided why they do not raise
different questions of safety and effectiveness.
Comments:

Proposed Labeling (see also 21 CFR parts 801 and 809 as
applicable)
18.

Submission includes proposed package labels and labeling (e.g.,
instructions for use, package insert, operator’s manual).
a.

Indications for use are stated in labeling and are identical to
Indications for Use form and 510(k) Summary (if 510(k)
Summary provided).

Labeling includes:
- Statements of conditions, purposes or uses for which
the device is intended (e.g., hazards, warnings,
precautions, contraindications) (21 CFR 801.5)
AND
- Includes adequate directions for use (see 21 CFR
801.5)
OR
- Submission states that device qualifies for exemption
per 21 CFR 801 Subpart D
35

Yes

N/A

*Page #

Labeling includes name and place of business of the
manufacturer, packer, or distributor (21 CFR 801.1).
Comments:

20.

Labeling includes the prescription statement (see 21 CFR
801.109(b)(1)) or Rx Only symbol (see also Section 502(a) of
the FD&C Act and FDA’s guidance “Alternative to Certain
Prescription Device Labeling Requirements,” available at
https://www.fda.gov/regulatory-information/search-fdaguidance-documents/alternative-certain-prescription-devicelabeling-requirements.
Select “N/A” if not indicated for prescription use.
Comments:

21.

The device has a device-specific guidance document, special
controls, and/or requirements in a device-specific classification
regulation regarding labeling that is applicable to the subject
device.
If “N/A” is selected, parts a and b below are omitted from the
checklist.
a.

The submission addresses labeling recommendations
outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended
to address the applicable statutory and/or regulatory
criteria.
Select “N/A” if there is no applicable device-specific
guidance. Select “No” if the submission does not include a
rationale for any omitted information or any alternative
approach as outlined above. Note that the adequacy of
how recommendations in a device-specific guidance, etc.,
have been addressed should be assessed during the
substantive review.

Yes

N/A

*Page #

Comments:
22.

If the device is an in vitro diagnostic device, provided labeling
includes all applicable information required per 21 CFR 809.10.
Select “N/A” if not an in vitro diagnostic device.
Comment:

Sterilization
If an in vitro diagnostic (IVD) device and sterilization is not applicable,
select “N/A.” The criteria in this section will be omitted from the
checklist if “N/A” is selected.

N/A

*Page #

Provided sterile, intended to be single-use
Requires processing during its use-life
Non-sterile when used (and no processing required)
Information regarding the sterility status of the device is not provided (if this
box is checked, please also check one of the two boxes below)
Sterility status not needed for this device (e.g., software-only device)
Sterility status needed or need unclear
This information will determine whether and what type of additional
information may be necessary for a substantial equivalence determination.
If “non-sterile when used” or “not provided and not needed” is selected, the
sterility-related criteria below are omitted from the checklist.
If information on sterility status is not provided, and it is needed or the need for
this information is unclear, select “No.”
The “Requires processing during its use-life” option refers to devices falling
into one of the four categories below:
• Supplied sterile and requires reprocessing prior to subsequent patient
use
• Supplied non-sterile and requires user to process the device for initial
use, as well as to reprocess the device after each use
• Reusable medical device (single-user) reprocessed between each use
• Single-use medical devices initially supplied as non-sterile to the user,
and requiring the user to process the device prior to its use
Please refer to the FDA guidance document “Reprocessing Medical Devices in
Health Care Settings: Validation Methods and Labeling,” available at
https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/reprocessing-medical-devices-health-care-settings-validationmethods-and-labeling, for additional information.
Comments:
23.

Assessment of the need for cleaning and subsequent disinfection
or sterilization information.

Identification of device and/or accessories, if applicable,
that are end user sterilized or disinfected.
Select “N/A” if no part of the device are accessories are
end user sterilized or disinfected.

Identification of device and/or accessories, if applicable,
that are reusable.
Select “N/A” if no part of the device or accessories, are
reusable.

Yes

N/A

*Page #

Comments:
24.

If the device and/or accessories, if applicable, are provided
sterile:
Select “N/A” if no part of the device or accessories are provided
sterile, otherwise complete a-f below.
a.

Sterilization method is stated for each device (including
dose for radiation sterilization)

A description of method to validate the sterilization
parameters is provided for each proposed sterilization
method (e.g., half-cycle method and full citation of FDArecognized standard, including date).
Note: the sterilization validation report is not required.

For devices sterilized using chemical sterilants such as
ethylene oxide (EO) and hydrogen peroxide, submission
states maximum levels of sterilant residuals remaining on
the device and sterilant residual limits.
Select “N/A” if not sterilized using chemical sterilants.

Sterility Assurance Level (SAL) stated

Submission includes description of packaging

Yes

N/A

*Page #

Comments:
25.

If the device and/or accessory, if applicable, is reusable or end
user sterilized or disinfected:
Select “N/A” if no part of the device or accessories are reusable
or end user sterilized or disinfected, otherwise complete a-d
below.
a.

Cleaning method is provided in labeling for each device
and/or accessory, if applicable.
Select “N/A” if not reusable and does not need cleaning
prior to disinfection or sterilization.

Disinfection method is provided in labeling for each device
and/or accessory, if applicable.
Select “N/A” if not disinfected (i.e., undergoes terminal
sterilization) prior to use.

Sterilization method is provided in labeling for each device
and/or accessory, if applicable.
Select “N/A” if not sterilized (i.e., undergoes disinfection)
prior to use.

Yes

N/A

*Page #

If device types in this submission are
included in the Reprocessing FR Notice, the
submission includes protocols and test
reports for validating the reprocessing
instructions.
Select “N/A” if the device type in the
submission is not included in the
Reprocessing FR Notice.

Comments:
26.

The device has a device-specific guidance document, special
controls, and/or requirement in a device-specific classification
regulation regarding sterility and/or reprocessing that is
applicable to the subject device.
If “N/A” is selected, parts a and b below are omitted from the
checklist.

Yes

N/A

*Page #

The submission includes sterility and/or reprocessing
information that addresses relevant mitigation measures set
forth in the special controls or device-specific classification
regulation applicable to the device.
OR
The submission uses alternative mitigation measures and
provides rationale why the alternative measures provide an
equivalent assurance of safety and effectiveness.
Select “N/A” if there are no applicable special controls or
device-specific classification regulation. Select “No” if the
submission does not include a rationale for any omitted
information or any alternative approach as outlined above.
Note that the adequacy of how such mitigation measures
have been addressed should be assessed during the
substantive review.
Comments:

Shelf-Life
27.

Proposed shelf life/ expiration date stated
OR
Statement that shelf-life is not applicable because of low
likelihood of time-dependent product degradation.
42

Yes

N/A

*Page #

For a sterile device, submission includes summary of methods
used to establish that device packaging will maintain a sterile
barrier for the entirety of the proposed shelf-life.
Select “N/A” if the device is not provided sterile.
Comments:

29.

Submission includes summary of methods used to establish that
device performance is maintained for the entirety of the proposed
shelf-life (e.g., mechanical properties, coating integrity, pH,
osmolality, etc.).
OR
Statement why performance data is not needed to establish
maintenance of device performance characteristics over the
shelf-life period.
Comments:

Biocompatibility
If an in vitro diagnostic (IVD) device, select “N/A.” The criteria in this
section will be omitted from the checklist if “N/A” is selected.

Yes

N/A

*Page #

Are direct or indirect tissue-contacting components
Are no direct or indirect tissue-contacting components
Information regarding tissue contact status of the device is not provided (if
this box checked, please also check one of the two boxes below)
Tissue contact information not needed for this device (e.g., softwareonly device)
Tissue contact information is needed or need unclear
This information will determine whether and what type of additional
information may be necessary for a substantial equivalence determination.
If “are no” or “not provided and not needed” is selected, the biocompatibilityrelated criteria below are omitted from the checklist. If information on the
tissue-contact status is not provided, and contact information is needed or its
contact status is unclear, select “No.”
An example of a direct tissue-contacting device would be an implant that has
direct contact with tissues during use. An example of an indirect tissuecontacting device would be fluid entering the body following passing through
device/device components not in direct contact with the tissue.
Comments:
30.

Submission includes a list identifying each tissue-contacting
device component (e.g., implant, delivery catheter) and
associated materials of construction for each component,
including identification of color additives, if present.
Comments:

31.

Submission identifies contact classification (e.g., surfacecontacting, less than 24 hour duration) for each tissue-contacting
device component (e.g., implant, delivery catheter).
Comments:

Contains Nonbinding Recommendations
Check “Yes” if item is present, “N/A” if it is not needed and “No” if it is
not included but needed.
*Submitters including the checklist with their submission should identify
the page numbers where requested information is located. Use the
comments section for an element if additional space is needed to identify
the location of supporting information.
For a biocompatibility assessment of tissue-contacting
32.
components, submission includes:
• Each relevant endpoint for the device (as identified in devicespecific guidance, or Attachment A of the FDA guidance
document entitled “Use of International Standard ISO 109931, ‘Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process,’”
available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/useinternational-standard-iso-10993-1-biological-evaluationmedical-devices-part-1-evaluation-and), has been addressed.
• For any testing performed, test protocol (including
identification and description of test article including whether
the test article is the device in its final finished form using the
recommended approach in Attachment F of “Use of
International Standard ISO 10993-1, ‘Biological evaluation
of medical devices - Part 1: Evaluation and testing within a
risk management process,’” methods, and pass/fail criteria),
and analysis of results (including tables with data points and
statistical analyses, where appropriate), as described in
Attachment E of the guidance document entitled “Use of
International Standard ISO 10993-1, ‘Biological evaluation
of medical devices - Part 1: Evaluation and testing within a
risk management process’” provided for each completed test.
OR
A statement that biocompatibility testing is not needed with a
rationale that considers all relevant endpoints (e.g., materials and
manufacturing/processing are identical to the predicate).

Yes

N/A

*Page #

Comments:
H.

Software

Yes

N/A

*Page #

Does contain software/firmware
Does not contain software/firmware
Information on whether device contains software/firmware is not provided
(if this box checked, please also check one of the two boxes below)
Software/firmware information not needed for this device (e.g., surgical
suture, condom)
Software/firmware information is needed or need unclear
This information will determine whether and what type of additional
information may be necessary for a substantial equivalence determination.
If “does not contain” or “not provided and not needed” is selected, the
software-related criteria below are omitted from the checklist. If information
on software is not provided, and this information is needed or the need is
unclear, select “No.”
Comments:
33.

Submission includes a statement of software level of concern and
rationale for the software level of concern
Comments:

34.

All applicable software documentation provided based on level
of concern identified by the submitter, as described in “Guidance
for the Content of Premarket Submissions for Software
Contained in Medical Devices,” available at
https://www.fda.gov/regulatory-information/search-fdaguidance-documents/guidance-content-premarket-submissionssoftware-contained-medical-devices, or the submission includes
information to establish that the submitter has otherwise met the
applicable statutory or regulatory criteria through an alternative
approach (i.e., the submitter has identified an alternate approach
with a rationale).
Note: This element is also applicable to non-internally generated
or off-the-shelf (OTS) software used in the device.
46

Yes

N/A

*Page #

Cybersecurity
Submission states that the device: (one of the below must be checked)
Does contain any external wired and/or wireless communication interfaces
(Wired: USB, ethernet, SD, CD, RGA, etc. or Wireless: Wi-Fi, Bluetooth, RF,
inductive, Cloud, etc.)
Does not contain external interfaces as described above
Information on whether device has external interfaces is not provided (if this
box is checked, please also check one of the two boxes below)
Cybersecurity information not needed for this device (e.g., surgical
suture, condom)
Cybersecurity information is needed or need unclear
This information will determine whether and what type of additional
information may be necessary for a substantial equivalence determination.
If “does not contain” or “not provided and not needed” is selected, the
cybersecurity criteria below are omitted from the checklist. If information on
cybersecurity is not provided, and this information is needed or the need is
unclear, select “No.”
35.

All applicable documentation identified by the submitter, as
described in “Guidance for the Content of Premarket
Submissions for Management of Cybersecurity in Medical
Devices,” available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/content-premarketsubmissions-management-cybersecurity-medical-devices-0.
OR
Submission includes information to establish that the submitter
has otherwise met the applicable statutory or regulatory criteria
through an alternative approach (i.e., the submitter has identified
an alternate approach with a rationale).
Comments:

Electrical Safety and EMC
47

Yes

N/A

*Page #

Does require electrical safety evaluation
Does not require electrical safety evaluation
Information on whether device requires electrical safety evaluation is not
provided (if this box checked, please also check one of the two boxes below)
Electrical safety information not needed for this device (e.g., surgical
suture, condom)
Electrical safety information needed or need unclear
This information will determine whether and what type of additional
information may be necessary for a substantial equivalence determination.
If “does not require” or “not provided and not needed” is selected, the
electrical safety criteria below are omitted from the checklist. If information on
electrical safety is not provided, and it is needed or the need for this
information is unclear, select “No.”
36.

Submission includes evaluation of electrical safety (e.g., per IEC
60601-1, or equivalent FDA-recognized standard, and if
applicable, a device-specific standard).
OR
Submission includes electrical safety evaluation using methods or
standards that are not FDA-recognized and submission includes
information to establish that the submitter has otherwise met the
applicable statutory or regulatory criteria through this alternative
approach (i.e., the submitter has identified alternate methods or
standards with a rationale).
Comments:

Yes

N/A

*Page #

Does require EMC evaluation
Does not require EMC evaluation
Information on whether device requires EMC evaluation not provided (if this
box checked, please also check one of the two boxes below)
EMC information not needed for this device (e.g., surgical suture,
condom)
EMC information needed or need unclear
This information will determine whether and what type of additional
information may be necessary for a substantial equivalence determination.
If “does not require” or “not provided and not needed” is selected, the EMC
criteria below are omitted from the checklist. If information on EMC is not
provided, and it is needed or the need for this information is unclear, select
“No.”
Comments:
37.

Submission includes evaluation of electromagnetic
compatibility (e.g., per IEC 60601-1-2 or equivalent FDArecognized standard and if applicable, a device-specific
standard).
OR
Submission includes electromagnetic compatibility evaluation
using methods or standards that are not FDA-recognized and
submission includes information to establish that the submitter
has otherwise met the applicable statutory or regulatory criteria
through this alternative approach (i.e., the submitter has
identified alternate methods or standards with a rationale).
Comments:

Yes

N/A

*Page #

Comments:
38.

Summaries of the non-clinical laboratory studies and full test
reports* are provided.
*Summary and full test report content recommendations can be
found in FDA’s guidance “Recommended Content and Format
of Non-Clinical Bench Performance Testing Information in
Premarket Submissions,” available at
https://www.fda.gov/regulatory-information/search-fdaguidance-documents/recommended-content-and-format-nonclinical-bench-performance-testing-information-premarket.
If a submitter chooses to declare conformity to a voluntary
consensus standard that FDA has recognized, submission of a
full test report may not be necessary. Refer to 9a. See FDA’s
guidance “Appropriate Use of Voluntary Consensus Standards
in Premarket Submissions for Medical Devices,” available at
https://www.fda.gov/regulatory-information/search-fdaguidance-documents/appropriate-use-voluntary-consensusstandards-premarket-submissions-medical-devices.
Select “N/A” if the submission appropriately does not include
performance data or there are no completed tests without a
Declaration of Conformity.
a.

Submission includes an explanation of how the data
generated from each test supports a finding of substantial
equivalence (e.g., comparison to predicate device testing,
dimensional analysis, etc.).
Select “N/A” if the submission does not include
performance data.
Comments:
50

The submission addresses performance data
recommendations outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended
to address the applicable statutory and/or regulatory
criteria.
Select “N/A” if there is no applicable device-specific
guidance. Select “No” if the submission does not include a
rationale for any omitted information or any alternative
approach as outlined above. Note that the adequacy of
how recommendations in a device-specific guidance, etc.,
have been addressed should be assessed during the
substantive review.

The submission includes performance data that addresses
relevant mitigation measures set forth in the special
controls or device-specific classification regulation
applicable to the device.
OR
The submission uses alternative mitigation measures and
provides rationale why the alternative measures provide an
equivalent assurance of safety and effectiveness.
Select “N/A” if there are no applicable special controls or
device-specific regulation. Select “No” if the submission
does not include a rationale for any omitted information or
any alternative approach as outlined above. Note that the
adequacy of how such mitigation measures have been
addressed should be assessed during the substantive
review.

Yes

N/A

*Page #

Comments:
51

Legible reprints or a summary of each article.

Discussion of how each article is applicable to support the
substantial equivalence of the subject device to the
predicate.

Yes

N/A

*Page #

Comments:
41.

For each completed animal study, the submission provides the
following:
Select “N/A” if no animal study was conducted. If “N/A” is
selected, parts a-c below are omitted from the checklist. Note
that this section does not address biocompatibility evaluations,
which are assessed in Section G of the checklist.
a.

Submission includes a study protocol which includes all
elements as outlined in 21 CFR 58.120

Submission includes final study report which includes all
elements outlined in 21 CFR 58.185

Submission contains a statement that the study was
conducted in compliance with applicable requirements in
the GLP regulation (21 CFR Part 58), OR, if the study was
not conducted in compliance with the GLP regulation, the
submission explains why the noncompliance would not
impact the validity of the study data provided to support a
substantial equivalence determination.
Comments:

Yes

N/A

*Page #

Submission indicates that device: (one of the below must be checked)
Is an in vitro diagnostic device
Is not an in vitro diagnostic device
If “is not” is selected, the performance data-related criteria below are
omitted from the checklist.
42.

Submission includes the following studies, as appropriate for the
device type, including associated protocol descriptions, study
results and line data:
a.

Precision/reproducibility

Accuracy (includes as appropriate linearity; calibrator or
assay traceability; calibrator and/or assay stability protocol
and acceptance criteria; assay cut-off; method comparison
or comparison to clinical outcome; matrix comparison; and
clinical reference range or cutoff).

Sensitivity (detection limits, LoB, LoD, LoQ where
relevant for the device type).

Analytical specificity
Comments:

43.

The device has a device-specific guidance document, special
controls, and/or requirement in a device-specific classification
regulation regarding performance data that is applicable to the
subject device.
If “N/A” is selected, parts a and b below are omitted from the
checklist.

Yes

N/A

*Page #

The submission includes performance data that addresses
relevant mitigation measures set forth in the special
controls or device-specific classification regulation
applicable to the device.
OR
The submission uses alternative mitigation measures and
provides rationale why the alternative measures provide an
equivalent assurance of safety and effectiveness.
Select “N/A” if there are no applicable special controls or
device-specific classification regulation. Select “No” if the
submission does not include a rationale for any omitted
information or any alternative approach as outlined above.
Note that the adequacy of how such mitigation measures
have been addressed should be assessed during the
substantive review.
Comments:

Contains Nonbinding Recommendations
Digital Signature Concurrence Table
Reviewer Sign-Off

Management Sign-Off
(digital signature
optional)*

*Management review of checklist and concurrence with decision required.

Contains Nonbinding Recommendations

Appendix B. Acceptance Checklist for Abbreviated
510(k)s
(Should be completed within 15 days of DCC receipt)
The following information is not intended to serve as a comprehensive review.
FDA recommends that the submitter include this completed checklist as part of the application.
510(k)#:

Date Received by DCC:

510(k) Lead Reviewer:
Center:

Office:

Division:

Decision: Accept_____ Refuse to Accept_____
If Accept, notify the submitter
If Refuse to Accept, notify submitter electronically and include a copy of this checklist.
Is an Addendum attached?: Yes No
Note: If an element is left blank on the checklist, it does not mean the checklist is incomplete;
it means the reviewer did not assess the element during the RTA review and that the element
will be assessed during substantive review.

Yes

1. Is the product a device (per section 201(h) of the FD&C Act) or a combination
product (per 21 CFR 3.2(e)) with a device constituent part subject to review in
a 510(k)?
If it appears not to be a device (per section 201(h) of the FD&C Act) or such a
combination product (per 21 CFR 3.2(e)), or you are unsure, consult with the
CDRH Product Jurisdiction Officer or the CBER Product Jurisdiction Officer to
determine the appropriate action, and inform management. Provide a summary of
the Product Jurisdiction Officer’s determination/recommendation/action in the
comment section below.
If the product does not appear to be a device or such a combination product, mark
“No.”
Comments:
56

N/A

Contains Nonbinding Recommendations

2. Is the submission with the appropriate Center?
If the product is a device or a combination product with a device constituent part, is
it subject to review by the Center in which the submission was received? If you
believe the submission is not with the appropriate Center or you are unsure, consult
with the CDRH Product Jurisdiction or the CBER Product Jurisdiction Officer to
determine the appropriate action and inform your management. Provide a summary
of the Product Jurisdiction Officer’s determination/recommendation/action in the
comment section below.
If submission should not be reviewed by your Center mark “No.”
Comments:
3. If a Request for Designation (RFD) was submitted for the device or
combination product with a device constituent part and assigned to your
center, identify the RFD # and confirm the following:
(a) Is the device or combination product the same (e.g., design,
formulation) as that presented in the RFD submission?
(b) Are the indications for use for the device or combination product
identified in the 510(k) the same as those identified in the RFD
submission?
If you believe the product or the indications presented in the 510(k) have changed
from the RFD, or you are unsure, consult with the CDRH Product Jurisdiction
Officer or the CBER Product Jurisdiction Officer to determine the appropriate
action and inform your management. Provide summary of Product Jurisdiction
Officer’s determination/recommendation/action in the comment section below.
If the answer to either question above is no, mark “No.” If there was no RFD, mark
“N/A.”
Comments:
4. Is the submission for a combination product that contains as a constituent
part a drug that has the same active moiety as an approved drug with
exclusivity as described in 21 USC 503(g)(5)(C)(ii)-(v) (section 503(g)(5)(C)(ii)(v) of the FD&C Act)?
If “Yes,” then contact the CDRH Product Jurisdiction Officer or CBER Product
Jurisdiction Officer to determine the appropriate action and inform your
management. Provide the summary of the Product Jurisdiction Officer’s
determination/recommendation/action in the comment section below.
Comments:

Contains Nonbinding Recommendations

5. Is this device type eligible for a 510(k) submission?
If a 510(k) does not appear to be appropriate (e.g., Class III type and PMA
required, or Class I or II type and 510(k)-exempt), consult with the appropriate
CDRH or CBER staff during the acceptance review, provide a summary of the
discussion with them, and indicate their recommendation/action in the comment
section below. If 510(k) is not the appropriate regulatory submission, mark “No.”
Comments:
6. Is there a pending PMA for the same device with the same indications for use?
If “Yes,” consult your management and CDRH Office of Product Evaluation and
Quality/Office of Regulatory Programs/Division of Regulatory Programs 1
(Submission Support) (OPEQ/ORP/DRP1) or appropriate CBER staff to determine
the appropriate action.
Comments:
7. If clinical studies have been submitted, is the submitter the subject of an
Application Integrity Policy (AIP)?
If “Yes,” consult with the CDRH Office of Product Evaluation and Quality/Office
of Clinical Evidence and Analysis/Division of Clinical Science and Quality
(OPEQ/OCEA/DCEA1) or CBER Office of Compliance and Biologics
Quality/Division of Inspections and Surveillance/Bioresearch Monitoring Branch
(OCBQ/DIS/BMB) to determine the appropriate action, provide a summary of the
discussion with them, and indicate their recommendation/action.
If no clinical studies have been submitted, mark “N/A.” Check on the AIP list at
https://www.fda.gov/inspections-compliance-enforcement-and-criminalinvestigations/application-integrity-policy/application-integrity-policy-list.
Comments:
•
•
•
•
•

If the answer to 1 or 2 appears to be “No,” then stop review of the 510(k) and
contact the CDRH Product Jurisdiction Officer or CBER Product Jurisdiction
Officer.
If the answer to 3a or 3b appears to be “No,” then stop the review and contact
the CDRH Product Jurisdiction Officer or CBER Product Jurisdiction Officer.
If the answer to 4 is “Yes,” then contact the CDRH Product Jurisdiction Officer
or CBER Product Jurisdiction Officer, provide a summary of the discussion with
them, and indicate their recommendation/action.
If the answer to 5 is “No”, the lead reviewer should consult division management
and other Center resources to determine the appropriate action.
If the answer to 6 is “Yes,” then stop review of the 510(k), contact
CDRH/OPEQ/ORP/DRP1, or appropriate CBER staff.
58

Contains Nonbinding Recommendations
•

If the answer to 7 is “Yes,” then contact CDRH/OPEQ/OCEA/DCEA1 or
CBER/OCBQ/DIS/BMB, provide a summary of the discussion with DCEA1 or
BMB Staff, and indicate their recommendation/action.

Abbreviated 510(k) Criteria
(See “The Abbreviated 510(k) Program,” available at https://www.fda.gov/regulatory-information/searchfda-guidance-documents/abbreviated-510k-program and “Format for Traditional and Abbreviated 510(k)s,”
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditionaland-abbreviated-510ks)
In order to qualify for review as an Abbreviated 510(k), one of the following criteria (1 or 2 or 3) should be
met. Submission should be converted and reviewed as a Traditional 510(k) if one of these criteria is not
met. Complete the Refuse to Accept Checklist for a Traditional 510(k) if submission is converted.
Yes

1. Submission relies on a guidance document and a summary report is provided
that:
Select “N/A” if submission does not rely on any guidance document(s). If “Yes,”
address parts a and b below.
a.

Includes the device description, the manufacturer’s device design
requirements, risk management information, and a description of test
methods used to address performance characteristics.

Includes a description of how the guidance document was used to satisfy the
requirements of 21 CFR 807.87 (e.g., data to support substantial
equivalence) and lists any deviations, that is any alternative methods used to
demonstrate substantial equivalence that is not described in the guidance.
Select “No” if the sponsor does not address whether there were deviations.

Comments:
2. Submission relies on special control(s) to demonstrate substantial equivalence
and a summary report is provided that:
Select “N/A” if submission does not rely on any special controls. If “Yes,” address
parts a-d below.
a.

Includes the device description, the manufacturer’s device design
requirements, risk management information, and a description of test
methods used to address performance characteristics.

Includes a description of how the special control(s) was satisfied.
59

N/A

Contains Nonbinding Recommendations

Comments:
3. Submission relies on voluntary consensus standard(s) (See section 514(c) of the
FD&C Act). This includes both FDA-recognized and non-recognized consensus
standards.
Select “N/A” if submission does not rely on any voluntary consensus standard(s). If
“Yes,” address part a below.
a.

The submission cites FDA-recognized voluntary consensus standard(s).
i.

The submission includes a Declaration of Conformity (DOC) as
outlined in FDA’s guidance “Appropriate Use of Voluntary Consensus
Standards in Premarket Submissions for Medical Devices,” available at
https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/appropriate-use-voluntary-consensus-standards-premarketsubmissions-medical-devices.
OR
If citing general use of a standard as noted in FDA’s guidance
“Appropriate Use of Voluntary Consensus Standards in Premarket
Submissions for Medical Devices,” the basis of such use is included
along with the underlying information or data that supports how the
standard was used.

The submission cites non-FDA-recognized voluntary consensus
standard(s).
i.

The basis of use is included along with the underlying information or
data that supports how the standard was used.

Comments:
Does the submission meet one of the criteria above?
Yes, submission meets criteria for an Abbreviated 510(k). Continue with the
remainder of this checklist below.
No, submission does not meet criteria for an Abbreviated 510(k). Discontinue this
RTA checklist, convert to a Traditional and apply the Traditional checklist.

Yes

*Page #
60

Contains Nonbinding Recommendations
1.

Submission contains a Table of Contents.

Each section is labeled (e.g., headings or tabs designating Device Description
section, Labeling section, etc.).

Type of 510(k) is identified (i.e., Traditional, Abbreviated, or Special)
If type of 510(k) is not designated, review as a Traditional 510(k).
Comments:

Elements of a Complete Submission (RTA Items)
(21 CFR 807.87 unless otherwise indicated)
Submission should be designated RTA if not addressed
•

•

Check “Yes” if item is present, “N/A” if it is not needed and “No” if it is
not included but needed.
*Submitters including the checklist with their submission should
identify the page numbers where requested information is located. Use
the comments section for an element if additional space is needed to
identify the location of supporting information.
A. Administrative
1.

Yes

N/A

*Page #

All content used to support the submission is written in English
(including translations of test reports, literature articles, etc.).
Comments:

Device trade/proprietary name

Device class and panel OR
Classification regulation OR
Statement that device has not been classified with rationale
for that conclusion

Yes

N/A

*Page #

Comments:
3.

Submission contains a Truthful and Accuracy Statement per 21
CFR 807.87(l).
See recommended format (https://www.fda.gov/medicaldevices/premarket-notification-510k/premarket-notificationtruthful-and-accurate-statement).
Comments:

Submission is a Class III 510(k) Device.
Select “N/A” only if submission is not a Class III 510(k).
62

Yes

N/A

*Page #

Comments:
7.

Submission contains clinical data.
Select “N/A” if the submission does not contain clinical data. If
“N/A” is selected, parts a, b, and c below are omitted from the
checklist.
a.

Submission includes completed Certification of
Compliance with requirements of ClinicalTrials.gov Data
Bank (FDA Form 3674, available at
https://www.fda.gov/media/69901/download) (42 U.S.C.
282(j)(5)(B)) for each applicable device clinical trial
included in the submission.
Select “N/A” if the submitted clinical data is not an
“applicable device clinical trial” as defined in Title VIII of
FDAAA, Sec. 801(j)

Yes

N/A

*Page #

For multicenter clinical investigations involving both
United States (US) and outside United States (OUS) sites,
part (i) should be addressed for the US sites and part (ii)
should be addressed for the OUS sites. 21 CFR 812.28
applies to all OUS clinical investigations that enroll the
first subject on or after February 21, 2019.
Please refer to the guidance document entitled “Acceptance
of Clinical Data to Support Medical Device Applications
and Submissions - Frequently Asked Questions,” available
at https://www.fda.gov/regulatory-information/search-fdaguidance-documents/acceptance-clinical-data-supportmedical-device-applications-and-submissions-frequentlyasked, for more information.
i. For each clinical investigation conducted in the US, the
submission includes a statement of compliance with 21
CFR parts 50, 56, and 812.
OR
The submission includes a brief statement of the
reason for noncompliance with 21 CFR parts 50,56 and
812.
Select “N/A” if the clinical investigations were
conducted solely OUS.

Yes

N/A

*Page #

Comments:

The submission identifies prior submissions for the same device
included in the current submission (e.g., submission numbers for
a prior not substantially equivalent [NSE] determination, prior
deleted or withdrawn 510(k), Q-Submission, IDE, PMA, etc.).
OR
States that there were no prior submissions for the subject
device.
Prior submissions (or no prior submissions) for this device
should be included in Section F (prior related submissions) of
the CDRH Premarket Review Submission Cover Sheet form
(Form 3514, available at
https://www.fda.gov/media/72421/download). This information
may also be included in the Cover Letter (i.e., as a statement
that there were no prior submissions for the device or a listing
of the number(s) of the prior submissions).

Yes

N/A

*Page #

Comments:
Combination Product Provisions – Per 503(g) of the FD&C Act.
Select “N/A” if the product is not a combination product. 21 CFR
3.2(e). The remaining criteria in this section will be omitted from the
checklist if "N/A" is selected. If you are unsure if the product is a
combination product, consult with the CDRH Product Jurisdiction
Officer or CBER Product Jurisdiction Officer.
9.

Submission identifies the product as a combination product.

10.

The combination product contains as a constituent part an
approved drug as defined in section 503(g)(5)(B) of the FD&C
Act. Select “N/A” if the combination product does not contain
as a constituent part an approved drug. Please also select “N/A”
if a right of reference or use for the drug constituent part(s) is
included with the submission. If “N/A” is selected, part a below
is omitted from the checklist.
a.

The submission includes appropriate patent statement or
certification and a statement that the submitter will give
notice, as applicable. See 503(g)(5)(A)&(C).
Comments:

Device Description

The submission addresses device description
recommendations outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended
to address the applicable statutory and/or regulatory
criteria.
Select “N/A” if there is no applicable device-specific
guidance. Select “No” if the submission does not include a
rationale for any omitted information or any alternative
approach as outlined above. Note that the adequacy of how
recommendations in a device-specific guidance, etc., have
been addressed should be assessed during the substantive
review.

The submission includes device description information
that addresses relevant mitigation measures set forth in the
special controls or device-specific classification regulation
applicable to the device.
OR
The submission uses alternative mitigation measures and
provides rationale why the alternative measures provide an
equivalent assurance of safety and effectiveness.
Select “N/A” if there are no applicable special controls or
device-specific classification regulation. Select “No” if the
submission does not include a rationale for any omitted
information or any alternative approach as outlined above.
Note that the adequacy of how such mitigation measures
have been addressed should be assessed during the
substantive review.

Yes

N/A

*Page #

Comments:
67

Yes

N/A

*Page #

Comments:
13.

The submission includes descriptive information for the device,
including the following:
a.

A description of the principle of operation or mechanism of
action for achieving the intended effect.

A list and description of each device for which clearance is
requested.
Select “N/A” if there is only one device or model. “Device”
may refer to models, part numbers, various sizes, etc.

Submission contains representative engineering drawing(s),
schematics, illustrations, photos and/or figures of the
device.
OR
Submission includes a statement that engineering drawings,
schematics, etc. are not applicable to the device (e.g.,
device is a reagent and figures are not pertinent to describe
the device).
In lieu of engineering drawings, schematics, etc. of each
device to be marketed, “representative” drawings, etc. may
be provided, where “representative” is intended to mean
that the drawings, etc. provided capture the differences in
design, size, and other important characteristics of the
various models, sizes, or versions of the device(s) to be
marketed.
Comments:

Submission includes a list of all accessories to be marketed
with the subject device.

Submission includes a description (as detailed in item
13a., 13b., and 13d. above) of each accessory.
Select “N/A” if the accessory(ies) has been previously
cleared, or is exempt, and the proposed indications for use
are consistent with the cleared indications.

A 510(k) number is provided for each accessory that
received a prior 510(k) clearance
AND
A statement is provided that identifies accessories that have
not received prior 510(k) clearance.

Yes

N/A

*Page #

Comments:
C.

Substantial Equivalence Discussion
15.

Submitter has identified a predicate device(s), including the
following information:
a.

Predicate device identifier provided (e.g., 510(k) number,
De Novo number, reclassified PMA number, classification
regulation reference, if exempt (e.g., 21 CFR 872.3710), or
statement that the predicate is a preamendment device).
For predicates that are preamendments devices, information
is provided to document preamendments status.
Information regarding documenting preamendment status
is available online (https://www.fda.gov/medicaldevices/quality-and-compliance-medicaldevices/preamendment-status).

Yes

N/A

*Page #

Comments:
16.

Submission includes a comparison of the following for the
predicate(s) and subject device and a discussion why any
differences between the subject and predicate(s) do not impact
safety and effectiveness [see section 513(i)(1)(A) of the FD&C
Act and 21 CFR 807.87(f)].
See “The 510(k) Program: Evaluating Substantial Equivalence
in Premarket Notifications [510(k)]” guidance document,
available at https://www.fda.gov/regulatory-information/searchfda-guidance-documents/510k-program-evaluating-substantialequivalence-premarket-notifications-510k for more information
on comparing intended use and technological characteristics.
a.

Indications for use
If there are no differences between the subject device and
the predicate(s) with respect to indications and intended
use, this should be explicitly stated.

Yes

N/A

*Page #

Submission includes proposed package labels and labeling (e.g.,
instructions for use, package insert, operator’s manual).
a.

Indications for use are stated in labeling and are identical to
Indications for Use form and 510(k) Summary (if 510(k)
Summary provided).

18.

Labeling includes name and place of business of the
manufacturer, packer, or distributor (21 CFR 801.1).
Comments:

19.

The submission addresses labeling recommendations
outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended
to address the applicable statutory and/or regulatory
criteria.
Select “N/A” if there is no applicable device-specific
guidance. Select “No” if the submission does not include a
rationale for any omitted information or any alternative
approach as outlined above. Note that the adequacy of how
recommendations in a device-specific guidance, etc., have
been addressed should be assessed during the substantive
review.

The submission includes labeling information that
addresses relevant mitigation measures set forth in the
special controls or device-specific classification regulation
applicable to the device.
OR
The submission uses alternative mitigation measures and
provides rationale why the alternative measures provide an
equivalent assurance of safety and effectiveness.
Select “N/A” if there are no applicable special controls or
device-specific classification regulation. Select “No” if the
submission does not include a rationale for any omitted
information or any alternative approach as outlined above.
Note that the adequacy of how such mitigation measures
have been addressed should be assessed during the
substantive review.

Yes

N/A

*Page #

Comments:
72

Yes

N/A

*Page #

Comment:
E.

Sterilization
If an in vitro diagnostic (IVD) device and sterilization is not
applicable, select “N/A.” The criteria in this section will be omitted
from the checklist if “N/A” is selected.

N/A

*Page #

Provided sterile, intended to be single-use
Requires processing during its use-life
Non-sterile when used (and no processing required)
Information regarding the sterility status of the device is not provided (if
this box is checked, please also check one of the two boxes below)
Sterility status not needed for this device (e.g., software-only device)
Sterility status needed or need unclear
This information will determine whether and what type of additional
information may be necessary for a substantial equivalence determination.
If “non-sterile when used” or “not provided and not needed” is selected, the
sterility-related criteria below are omitted from the checklist.
If information on sterility status is not provided, and it is needed or the need
for this information is unclear, select “No.”
The “Requires processing during its use-life” option refers to devices falling
into one of the four categories below:
• Supplied sterile and requires reprocessing prior to subsequent patient
use
• Supplied non-sterile and requires user to process the device for initial
use, as well as to reprocess the device after each use
• Reusable medical device (single-user) reprocessed between each use
• Single-use medical devices initially supplied as non-sterile to the user,
and requiring the user to process the device prior to its use
Please refer to the guidance document titled “Reprocessing Medical Devices
in Health Care Settings: Validation Methods and Labeling,” available at
https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/reprocessing-medical-devices-health-care-settings-validationmethods-and-labeling, for additional information.
Comments:
22.

Assessment of the need for cleaning and subsequent disinfection
or sterilization information.

Identification of device and/or accessories, if applicable,
that are end user sterilized or disinfected.
Select “N/A” if no part of the device or accessories are end
user sterilized or disinfected.

Identification of device and/or accessories, if applicable,
that are reusable.
Select “N/A” if no part of the device or accessories are
reusable.

Yes

N/A

*Page #

Comments:
23.

If the device and/or accessories, if applicable, are provided
sterile:
Select “N/A” if no part of the device or accessories are provided
sterile, otherwise complete a-f below.
a.

Sterilization method is stated for each device (including
dose for radiation sterilization)

Sterility Assurance Level (SAL) stated

Submission includes description of packaging

Yes

N/A

*Page #

Comments:
24.

Cleaning method is provided in labeling for each device
and/or accessory, if applicable.
Select “N/A” if not reusable and does not need cleaning
prior to disinfection or sterilization.

Disinfection method is provided in labeling for each device
and/or accessory, if applicable.
Select “N/A” if not disinfected (i.e., undergoes terminal
sterilization) prior to use.

Sterilization method is provided in labeling for each device
and/or accessory, if applicable.
Select “N/A” if not sterilized (i.e., undergoes disinfection)
prior to use.

Yes

N/A

*Page #

If device types in this submission are included in the
Reprocessing FR Notice, the submission includes
protocols and test reports for validating the
reprocessing instructions.
Select “N/A” if the device type in the submission is not
included in the Reprocessing FR Notice.

Comments:
25.

The device has a device-specific guidance document, special
controls, and/or requirement in a device-specific classification
regulation regarding sterility and/or reprocessing that is
applicable to the subject device
If “N/A” is selected, parts a and b below are omitted from the
checklist.

Yes

N/A

*Page #

Shelf-Life
26.

Proposed shelf-life/expiration date stated
OR
Statement that shelf-life is not applicable because of low
likelihood of time-dependent product degradation
78

Yes

N/A

*Page #

28.

Submission includes summary of methods used to establish that
device performance is maintained for the entirety of the
proposed shelf-life (e.g., mechanical properties, coating
integrity, pH, osmolality, etc.).
OR
Statement why performance data is not needed to establish
maintenance of device performance characteristics over the
shelf-life period.
Comments:

Biocompatibility
If an in vitro diagnostic (IVD) device, select “N/A.” The criteria in this
section will be omitted from the checklist if “N/A” is selected.

Yes

N/A

*Page #

Are direct or indirect tissue-contacting components
Are no direct or indirect tissue-contacting components
Information regarding tissue contact status of the device is not provided (if
this box checked, please also check one of the two boxes below)
Tissue contact information not needed for this device (e.g., softwareonly device)
Tissue contact information is needed or need unclear
This information will determine whether and what type of additional
information may be necessary for a substantial equivalence determination.
If “are no” or “not provided and not needed” is selected, the
biocompatibility-related criteria below are omitted from the checklist. If
information on the tissue-contact status is not provided, and contact
information is needed or its contact status is unclear, select “No.”
An example of a direct tissue-contacting device would be an implant that has
direct contact with tissues during use. An example of an indirect tissuecontacting device would be fluid entering the body following passing through
device/device components not in direct contact with the tissue.
Comments:
29.

30.

Submission identifies contact classification (e.g., surfacecontacting, less than 24 hour duration) for each tissue-contacting
device component (e.g., implant, delivery catheter).
Comments:

Contains Nonbinding Recommendations
Check “Yes” if item is present, “N/A” if it is not needed and “No” if it is
not included but needed.
*Submitters including the checklist with their submission should
identify the page numbers where requested information is located. Use
the comments section for an element if additional space is needed to
identify the location of supporting information.
31. For a biocompatibility assessment of tissue-contacting
components, submission includes:
• Each relevant endpoint for the device (as identified in
device-specific guidance, or Attachment A of the FDA
guidance document entitled “Use of International Standard
ISO 10993-1, ‘Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management
process,’” available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/useinternational-standard-iso-10993-1-biological-evaluationmedical-devices-part-1-evaluation-and), has been addressed.
• For any testing performed, test protocol (including
identification and description of test article including
whether the test article is the device in its final finished form
using the recommended approach in Attachment F of “Use
of International Standard ISO 10993-1, ‘Biological
evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process,’” methods, and
pass/fail criteria), and analysis of results (including tables
with data points and statistical analyses, where appropriate),
as described in Attachment E of the guidance document
entitled “Use of International Standard ISO 10993-1,
‘Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process’”
provided for each completed test.
OR
A statement that biocompatibility testing is not needed with a
rationale that considers all relevant endpoints (e.g., materials and
manufacturing/processing are identical to the predicate).

Yes

N/A

*Page #

Comments:
H.

Software

Yes

N/A

*Page #

Does contain software/firmware
Does not contain software/firmware
Information on whether device contains software/firmware is not provided
(if this box checked, please also check one of the two boxes below)
Software/firmware information not needed for this device (e.g.,
surgical suture, condom)
Software/firmware information is needed or need unclear
This information will determine whether and what type of additional
information may be necessary for a substantial equivalence determination.
If “does not contain” or “not provided and not needed” is selected, the
software-related criteria below are omitted from the checklist. If information
on software is not provided, and this information is needed or the need is
unclear, select “No.”
Comments:
32.

Submission includes a statement of software level of concern
and rationale for the software level of concern.
Comments:

33.

All applicable software documentation provided based on level
of concern identified by the submitter, as described in “Guidance
for the Content of Premarket Submissions for Software
Contained in Medical Devices,” available at
https://www.fda.gov/regulatory-information/search-fdaguidance-documents/guidance-content-premarket-submissionssoftware-contained-medical-devices, or the submission includes
information to establish that the submitter has otherwise met the
applicable statutory or regulatory criteria through an alternative
approach (i.e., the submitter has identified an alternate approach
with a rationale).
Note: This element is also applicable to non-internally
generated or off-the-shelf (OTS) software used in the device.
82

Yes

N/A

*Page #

Cybersecurity
Submission states that the device: (one of the below must be checked)
Does contain any external wired and/or wireless communication interfaces
(Wired: USB, ethernet, SD, CD, RGA, etc. or Wireless: Wi-Fi, Bluetooth, RF,
inductive, Cloud, etc.)
Does not contain external interfaces as described above
Information on whether device has external interfaces in not provided (if
this box is checked, please also check one of the two boxes below)
Cybersecurity information not needed for this device (e.g., surgical
suture, condom)
Cybersecurity information is needed or need unclear
This information will determine whether and what type of additional
information may be necessary for a substantial equivalence determination.
If “does not contain” or “not provided and not needed” is selected, the
cybersecurity criteria below are omitted from the checklist. If information on
cybersecurity is not provided, and this information is needed or the need is
unclear, select “No.”
34.

All applicable documentation identified by the submitter, as
described in Guidance for the “Content of Premarket
Submissions for Management of Cybersecurity in Medical
Devices,” available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/content-premarketsubmissions-management-cybersecurity-medical-devices-0.
OR
Submission includes information to establish that the submitter
has otherwise met the applicable statutory or regulatory criteria
through an alternative approach (i.e., the submitter has identified
an alternate approach with a rationale).
Comments:

Electrical Safety and EMC
83

Yes

N/A

*Page #

Does require electrical safety evaluation
Does not require electrical safety evaluation
Information on whether device requires electrical safety evaluation not
provided (if this box checked, please also check one of the two boxes
below)
Electrical safety information not needed for this device (e.g., surgical
suture, condom)
Electrical safety information needed or need unclear
This information will determine whether and what type of additional
information may be necessary for a substantial equivalence determination.
If “does not require” or “not provided and not needed” is selected, the
electrical safety criteria below are omitted from the checklist. If information
on electrical safety is not provided, and it is needed or the need for this
information is unclear, select “No.”
Comments:
35.

Submission includes evaluation of electrical safety (e.g., per IEC
60601-1, or equivalent FDA-recognized standard, and if
applicable, a device-specific standard).
OR
Submission includes electrical safety evaluation using methods
or standards that are not FDA-recognized and submission
includes information to establish that the submitter has
otherwise met the applicable statutory or regulatory criteria
through this alternative approach (i.e., the submitter has
identified alternate methods or standards with a rationale).
Comments:

Yes

N/A

*Page #

Does require EMC evaluation
Does not require EMC evaluation
Information on whether device requires EMC evaluation not provided (if
this box checked, please also check one of the two boxes below)
EMC information not needed for this device (e.g., surgical suture,
condom)
EMC information needed or need unclear
This information will determine whether and what type of additional
information may be necessary for a substantial equivalence determination.
If “does not require” or “not provided and not needed” is selected, the EMC
criteria below are omitted from the checklist. If information on EMC is not
provided, and it is needed or the need for this information is unclear, select
“No.”
Comments:
36.

Yes

N/A

*Page #

Comments:
37.

Summaries of the non-clinical laboratory studies and full test
reports* are provided.
*Summary and full test report content recommendations can
be found in FDA’s guidance “Recommended Content and
Format of Non-Clinical Bench Performance Testing
Information in Premarket Submissions,” available at
https://www.fda.gov/regulatory-information/search-fdaguidance-documents/recommended-content-and-format-nonclinical-bench-performance-testing-information-premarket.
If a submitter chooses to declare conformity to a voluntary
consensus standard that FDA has recognized, submission of a
full test report may not be necessary. Refer to Abbreviated
Criteria #3. See FDA’s guidance “Appropriate Use of
Voluntary Consensus Standards in Premarket Submissions for
Medical Devices,” available at
https://www.fda.gov/regulatory-information/search-fdaguidance-documents/appropriate-use-voluntary-consensusstandards-premarket-submissions-medical-devices.
Select “N/A” if the submission appropriately does not include
performance data or there are no completed tests without a
Declaration of Conformity.
a.

Yes

N/A

*Page #

The submission addresses performance data
recommendations outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended
to address the applicable statutory and/or regulatory
criteria.
Select “N/A” if there is no applicable device-specific
guidance. Select “No” if the submission does not include a
rationale for any omitted information or any alternative
approach as outlined above. Note that the adequacy of how
recommendations in a device-specific guidance, etc., have
been addressed should be assessed during the substantive
review.

The submission includes performance data that addresses
relevant mitigation measures set forth in the special
controls or device-specific classification regulation
applicable to the device.
OR
The submission uses alternative mitigation measures and
provides rationale why the alternative measures provide an
equivalent assurance of safety and effectiveness.
Select “N/A” if there are no applicable special controls or
device-specific classification regulation. Select “No” if the
submission does not include a rationale for any omitted
information or any alternative approach as outlined above.
Note that the adequacy of how such mitigation measures
have been addressed should be assessed during the
substantive review.
87

Yes

N/A

*Page #

If literature is referenced in the submission, submission
includes:
Select “N/A” if the submission does not reference literature. If
“N/A” is selected, parts a and b below are omitted from the
checklist.
Note that the applicability of the referenced article to support a
substantial equivalence finding should be assessed during the
substantive review; only the presence of a discussion is required
to support acceptance.
a.

Legible reprints or a summary of each article.

Discussion of how each article is applicable to support the
substantial equivalence of the subject device to the
predicate.
Comments:

40.

Submission includes a study protocol which includes all
elements as outlined in 21 CFR 58.120

Submission includes final study report which includes all
elements outlined in 21 CFR 58.185

Yes

N/A

*Page #

Submission includes the following studies, as appropriate for the
device type, including associated protocol descriptions, study
results and line data:
a.

Precision/reproducibility

Sensitivity (detection limits, LoB, LoD, LoQ where
relevant for the device type).

Analytical specificity
Comments:

42.

Yes

N/A

*Page #

The submission includes performance data that addresses
relevant mitigation measures set forth in the special
controls or device-specific classification regulation
applicable to the device.
OR
The submission uses alternative mitigation measures and
provides rationale why the alternative measures provide an
equivalent assurance of safety and effectiveness.
Select “N/A” if there are no applicable special controls or
device-specific classification regulation. Select “No” if the
submission does not include a rationale for any omitted
information or any alternative approach as outlined above.
Note that the adequacy of how such mitigation measures
have been addressed should be assessed during the
substantive review.
Comments:

Digital Signature Concurrence Table
Reviewer Sign-Off

Contains Nonbinding Recommendations
Management Sign-Off
(digital signature
optional)*

*Management review of checklist and concurrence with decision required.

Contains Nonbinding Recommendations

Appendix C. Acceptance Checklist for Special 510(k)s
(Should be completed within 15 days of DCC receipt)
The following information is not intended to serve as a comprehensive review.
FDA recommends that the submitter include this completed checklist as part of the application.
510(k)#:

Date Received by DCC:

510(k) Lead Reviewer:
Center:

Office:

Division:

Special 510(k) Factors
(See “The Special 510(k) Program,” available at https://www.fda.gov/regulatory-information/searchfda-guidance-documents/special-510k-program)
Please complete the below questions to determine if the 510(k) is appropriate for review as a Special
510(k). Complete the Refuse to Accept Checklist for a Traditional 510(k) if submission is converted.
Yes
No
1. 510(k) is submitted to modify a legally marketed device (predicate) AND
the Special 510(k) submission is submitted by the manufacturer legally
authorized to market the predicate device.
Comments:
2.

Performance data are needed to evaluate the change. If a manufacturer
determines under their design control procedures that no additional
verification or validation testing is necessary to evaluate a change,
manufacturers may submit these changes as a Special 510(k) with a clear
rationale supporting their conclusion that no performance data are necessary.
When FDA does not agree with the manufacturer's assessment, FDA intends to
92

Contains Nonbinding Recommendations
continue with the additional Special 510(k) factors.
Comments:
3.

There is a well-established method to evaluate the change. Well-established
methods include those used in the previously cleared 510(k), an FDArecognized consensus standard or FDA guidance document, qualified medical
device development tools (MDDTs), are widely available and accepted, or
found acceptable through a different premarket submission by the same
manufacturer of the predicate.
Comments:

The data be reviewed in a summary or risk analysis format. The results
from verification and validation associated with design or labeling changes
should be able to be placed in a summary or risk analysis format without losing
information necessary to support SE. Complete test reports should not be
submitted in a Special 510(k). If complete test reports are submitted, FDA
intends to assess whether the information can be reviewed in a summary format
before converting to a Traditional 510(k).
Comments:

Is the submission appropriate for review as a Special 510(k)? Answer Yes if the change
was submitted by the manufacturer of the predicate, well-established methods are available
for any performance data necessary, and performance data can be reviewed in a summary or
risk analysis format.
Yes, submission is appropriate for a Special 510(k). Continue checklist below.
No, submission is not appropriate for a Special 510(k). Discontinue this RTA checklist,
convert to a Traditional and apply the Traditional checklist.

Organizational Elements
Failure to include these items should not result in an RTA designation.
*Submitters including the checklist with their submission should identify the
page numbers where requested information located. Use the comments
section for an element if additional space is needed to identify the location of
supporting information.
1.

Submission contains a Table of Contents.

Each section is labeled (e.g., headings or tabs designating Device Description
section, Labeling section, etc.).

Yes

*Page #

Contains Nonbinding Recommendations
(e.g., 12-1, 12-2…).
4.

Type of 510(k) is identified (i.e., Traditional, Abbreviated, or Special)
If type of 510(k) is not designated, review as a Traditional 510(k).

Comments:

Elements of a Complete Submission (RTA Items)
(21 CFR 807.87 unless otherwise indicated)
Submission should be designated RTA if not addressed
•

•

Check “Yes” if item is present, “N/A” if it is not needed and “No” if it is
not included but needed.
*Submitters including the checklist with their submission should identify
the page numbers where requested information located. Use the
comments section for an element if additional space is needed to identify
the location of supporting information.
A. Administrative
1.

Yes

N/A

All content used to support the submission is written in English
(including translations of test reports, literature articles, etc.).
Comments:

Submission identifies the following (FDA recommends use of the
CDRH Premarket Review Submission Cover Sheet form (Form
3514, available at https://www.fda.gov/media/72421/download)):
a.

Device trade/proprietary name

Device class and panel OR
Classification regulation OR
Statement that device has not been classified with rationale for
that conclusion

Comments:
3.

Submission contains an Indications for Use Statement with Rx
94

*Page #

Yes

N/A

Comments:
4.

Submission contains a 510(k) Summary or 510(k) Statement.
Refer to 21 CFR 807.92 and 21 CFR 807.93 for contents of 510(k)
Summary and Statement, respectively. Adequacy of the content will
be assessed during substantive review.
Comments:

Submission is a Class III 510(k) Device.
Select “N/A” only if submission is not a Class III 510(k).
a.

Contains Class III Summary and Certification per 21 CFR
807.87(k).
See recommended content (https://www.fda.gov/medicaldevices/premarket-notification-510k/premarket-notificationclass-iii-certification-and-summary). Select “N/A” only if
submission is not a Class III 510(k).

Comments
7.

*Page #

Yes

N/A

If there were prior submissions, the submitter has identified
where in the current submission any issues related to a
determination of substantial equivalence from prior
submissions for this device are addressed.
To address this criterion, it is recommended that the
submission include a separate section with the prior
submission number(s), a copy of the FDA feedback (e.g., letter,
meeting minutes), and a statement of how or where in the
submission this prior feedback was addressed. Note that
adequacy of how the feedback was addressed will be assessed
during the substantive review.
Select “N/A” if the submitter states there were no prior
submissions.

Comments:
8.

The submission utilizes voluntary consensus standard(s) (See
section 514(c) of the FD&C Act). This includes both FDArecognized and non-recognized consensus standards. Select “N/A”
if the submission does not utilize voluntary consensus standards.
a.

The submission cites FDA-recognized voluntary consensus
standard(s).

*Page #

Yes

N/A

Combination Product Provisions – Per 503(g) of the FD&C Act.
Select N/A if the product is not a combination product. 21 CFR 3.2(e).
The remaining criteria in this section will be omitted from the checklist if
"N/A" is selected. If you are unsure if the product is a combination
product, consult with the CDRH Product Jurisdiction Officer or CBER
Product Jurisdiction Officer.
9.

Submission identifies the product as a combination product.

10.

The combination product contains as a constituent part an
approved drug as defined in section 503(g)(5)(B) of the FD&C
Act. Select “N/A” if the combination product does not contain as a
constituent part an approved drug. Please also select “N/A” if a
right of reference or use for the drug constituent part(s) is included
with the submission. If “N/A” is selected, part a below is omitted
from the checklist.
97

*Page #

Yes

N/A

Comments:
B.

Device Description
11.

The device has a device-specific guidance document, special
controls, and/or requirements in a device-specific classification
regulation regarding the device description that is applicable to the
subject device.
If “N/A” is selected, parts a and b below are omitted from the
checklist.
a.

The submission addresses device description
recommendations outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended to
address the applicable statutory and/or regulatory criteria.
Select “N/A” if there is no applicable device-specific
guidance. Select “No” if the submission does not include a
rationale for any omitted information or any alternative
approach as outlined above. Note that the adequacy of how
recommendations in a device-specific guidance, etc., have
been addressed should be assessed during the substantive
review.

The submission includes device description information that
addresses relevant mitigation measures set forth in the special
controls or device-specific classification regulation applicable
to the device.
OR
The submission uses alternative mitigation measures and
provides rationale why the alternative measures provide an
equivalent assurance of safety and effectiveness.
Select “N/A” if there are no applicable special controls or
device-specific classification regulation. Select “No” if the
submission does not include a rationale for any omitted
information or any alternative approach as outlined above.
98

*Page #

Yes

N/A

Comments:
12.

Descriptive information is present and consistent within the
submission (e.g., the device description section is consistent with
the device description in the labeling).
Comments:

13.

The submission includes descriptive information for the device,
including the following:
a.

A description of the principle of operation or mechanism of
action for achieving the intended effect.

A description of proposed conditions of use, such as surgical
technique for implants; anatomical location of use; user
interface; how the device interacts with other devices; and/or
how the device interacts with the patient.

A list and description of each device for which clearance is
requested.
Select “N/A” if there is only one device or model. “Device”
may refer to models, part numbers, various sizes, etc.

Submission contains representative engineering drawing(s),
schematics, illustrations, photos and/or figures of the device.
OR
Submission includes a statement that engineering drawings,
schematics, etc. are not applicable to the device (e.g., device is
a reagent and figures are not pertinent to describe the device).
In lieu of engineering drawings, schematics, etc. of each
device to be marketed, “representative” drawings, etc. may be
provided, where “representative” is intended to mean that the
drawings, etc. provided capture the differences in design, size,
and other important characteristics of the various models,
sizes, or versions of the device(s) to be marketed.

Comments:
99

*Page #

Yes

N/A

Comments:
15.

Device is intended to be marketed with accessories and/or as part
of a system.
Select “N/A” if the device is not intended to be marketed with
accessories and/or as part of a system. If “N/A” is selected, parts
a-c below are omitted from the checklist.
a.

Submission includes a list of all accessories to be marketed
with the subject device.

A 510(k) number is provided for each accessory that received
a prior 510(k) clearance
AND
A statement is provided that identifies accessories that have
not received prior 510(k) clearance.

Comments:
C.

Substantial Equivalence Discussion
16.

Submitter has identified a predicate device(s), including the
following information:
a.

*Page #

Yes

N/A

The identified predicate(s) is consistent throughout the
submission (e.g., the predicate(s) identified in the Substantial
Equivalence section is the same as that listed in the 510(k)
Summary (if applicable) and that used in comparative
performance testing.

Comments:
17.

Submission includes a comparison of the following for the
predicate(s) and subject device and a discussion why any
differences between the subject and predicate(s) do not impact
safety and effectiveness [see section 513(i)(1)(A) of the FD&C Act
and 21 CFR 807.87(f)]
See the FDA guidance document “The 510(k) Program:
Evaluating Substantial Equivalence in Premarket Notifications
[510(k)],” available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/510k-programevaluating-substantial-equivalence-premarket-notifications-510k
for more information on comparing intended use and technological
characteristics.
a.

Indications for use
If there are no differences between the subject device and the
predicate(s) with respect to indications and intended use, this
should be explicitly stated.

*Page #

Yes

N/A

Design Control Activities
18.

Design Control Activities Summary includes all of the following:
a.

Identification of risk analysis method(s) used to assess the
impact of the modification on the device AND the results of
the analysis.

Identification of the device change(s).

Identification of all risks associated with each device change,
including identification of risks that are considered new
because of the change; and

Risk control measures to mitigate identified risks (e.g.,
labeling, verification).

Based on the Risk Analysis, an identification of the
verification and/or validation activities required to comply
with 21 CFR 820.30. This identification includes a summary
of test methods (including any protocol deviations),
acceptance criteria, results in a summary or risk analysis
format (e.g., basic descriptive statistics, where appropriate),
and why each is adequate to establish substantial equivalence.
If unchanged from a previous premarket submission, the
manufacturer references the location of protocols and
acceptance criteria by providing a submission and section
numbers.
For non-standardized test methods only:
i.
• A reference to the protocol used for the existing
device with an identification of any differences
(e.g., protocol, test conditions, pre-defined
acceptance criteria, sample size) from the
previous 510(k). If protocol changes were
made, the results summary describes why the
test methods, acceptance criteria, and results
102

*Page #

Yes

N/A

A signed statement by the manufacturer’s designated
individual(s) responsible for design control activities. Both
items below must be present to answer “Yes.”
i. Statement that, as required by the risk analysis, all
verification and validation activities were performed by
designated individual(s) and the results demonstrated
that the predetermined acceptance criteria were met.
ii. Statement that the submitter has complied and is not
currently in violation of the design control procedure
requirements as specified in 21 CFR 820.30 and the
records are available for review, upon request.

Comments:
E.

Proposed Labeling (see also 21 CFR parts 801 and 809 as applicable)
19.

Submission includes proposed package labels and labeling (e.g.,
instructions for use, package insert, operator’s manual).
a.

All changes in proposed labeling resulting from device
modification(s) are highlighted or prominently identified.
FDA recommends clean and redlined copies be provided.

Comments:

Digital Signature Concurrence Table
Reviewer Sign-Off

Management Sign-Off
(digital signature
optional)*

*Management review of checklist and concurrence with decision required.

103

*Page #

File Type	application/pdf
File Title	Guidance for Industry and
Author	Pamidimukkala, Geeta K
File Modified	2020-04-27
File Created	2019-09-12