Guidance Final-510(k) Review Program-2020 (002)

510(k) Third-Party Review Program

Guidance Final-510(k) Review Program-2020 (002)

OMB: 0910-0375

Document [pdf]

Download: pdf | pdf

Contains Nonbinding Recommendations

510(k) Third Party Review Program
Guidance for Industry,
Food and Drug Administration Staff,
and Third Party
Review Organizations
Document issued on March 12, 2020
The draft of this document was issued on September 14, 2018

This guidance supersedes “Implementation of Third Party Programs Under
the FDA Modernization Act of 1997; Final Guidance for Staff, Industry, and
Third Parties” issued on February 2, 2001, and “Guidance for Third Parties
and FDA Staff; Third Party Review of Premarket Notifications” issued on
September 28, 2004.

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

OMB Control No. 0910-0375
Current expiration date available at https://www.reginfo.gov
See additional PRA statement in Section XI of this guidance

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-2016-D-2565. 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 1500013 and complete title of the guidance in the request.

Contains Nonbinding Recommendations

Table of Contents
I.
II.

Introduction ....................................................................................................................... 4
Background ....................................................................................................................... 5
Basis for 3P510k Review Program ........................................................................................................... 5
General Overview of 3P510k Review Program ....................................................................................... 6

III.
IV.
V.
VI.

Scope................................................................................................................................... 7
Definitions .......................................................................................................................... 8
Factors Used in Determining Device Type Eligibility in the 3P510k Review Program10
Review of 510(k) Submissions by 3P510k Review Organizations .............................. 12
Determine device eligibility for 3P510k review ..................................................................................... 13
Assign a Product Specialist(s) and Technical Expert(s) to conduct the substantive review of a 510(k)
submission .......................................................................................................................................... 14
Obtain relevant FDA guidance(s) and information ................................................................................ 14
Early Interaction with FDA (as needed) ................................................................................................. 16
Ensure a submission is administratively complete ................................................................................. 16
Conduct the substantive review of a 510(k) submission ........................................................................ 17
Identify deficiencies in a 510(k) submission .......................................................................................... 18
Document a 510(k) review ..................................................................................................................... 19
Organize and submit a 510(k) submission including associated 3P510k review documentation ........ 20
Submit additional information upon FDA’s request............................................................................... 22
510(k) submission dispute resolution ..................................................................................................... 23

VII. Requirements and Recommendations for Recognition and Rerecognition of Third Party
Review Organizations ..................................................................................................... 24
Operational considerations ..................................................................................................................... 25
Management of impartiality ................................................................................................................... 25
Personnel involved in reviewing activities ............................................................................................. 26
Use of external Technical Experts .......................................................................................................... 28
Confidential information ........................................................................................................................ 28
Complaints regarding 510(k) Submitters................................................................................................ 29
Third Party Review Organization recordkeeping ................................................................................... 29

VIII. Content and Format of an Application for Initial Recognition and Rerecognition as a
3P510k Review Organization ......................................................................................... 30
(1)
(2)
(3)
(4)

Initial Recognition .................................................................................................................................. 31
Administrative information ............................................................................................................ 31
Prevention of conflicts of interest .................................................................................................. 33
Personnel qualifications ................................................................................................................ 33
Certification statements ................................................................................................................. 34
Rerecognition ......................................................................................................................................... 35
Recognition or Rerecognition Denial ..................................................................................................... 35

IX. Suspension or Recognition Withdrawal........................................................................ 36
X. Leveraging the International Medical Device Regulators Forum’s (IMDRF’s)
documents ........................................................................................................................ 37
XI. Paperwork Reduction Act of 1995................................................................................. 38

Contains Nonbinding Recommendations

510(k) Third Party Review Program
Guidance for Industry,
Food and Drug Administration Staff,
and Third Party Review Organizations
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.

Introduction

The 510(k) Third Party (3P510k) Review Program (formally known as the Accredited Persons
(AP) Program) is authorized under section 523 of the Federal Food, Drug, and Cosmetic (FD&C)
Act. 1 Under this authority, FDA recognizes third parties to review premarket notification
(510(k)) submissions and recommend the initial classification of certain devices. FDA’s
implementation of section 523 establishes a process for recognition of qualified third parties to
conduct the initial review of 510(k) submissions for certain low-to-moderate risk devices eligible
for review under the 3P510k Review Program within the Center for Devices and Radiological
Health (CDRH). 2 This guidance document also reflects amendments made to section 523 by the
FDA Reauthorization Act of 2017 (FDARA), 3 which directed FDA to issue guidance 4 on the
factors that will be used in determining whether a class I or class II device type, or subset of such
device types, is eligible for review by an accredited person.
For the current edition of the FDA-recognized standards referenced in this document, see the
FDA Recognized Consensus Standards Database. 5 For more information regarding use of
consensus standards in regulatory submissions, please refer to FDA guidance entitled,
1

Section 523 of the FD&C Act uses the terms “accredited persons,” “accredit,” “accredited,” “accreditation,”
“reaccredit,” “reaccredited,” and “reaccreditation.” The guidance does not use those statutory terms but rather
defines such terms as “recognition,” and “rerecognition” as synonymous terms. These alternative terms are used in
this guidance to harmonize the terms used by FDA and in the FD&C Act with those in the International Medical
Device Regulators Forum (IMDRF) Medical Device Single Audit Program (MDSAP) documents and are defined in
Section IV of this guidance.
2
Currently, the Center for Biologics Evaluation and Research does not regulate devices of the types subject to this
guidance.
3
Pub. L. 115-52
4
See section 523(a)(3)(B) of the FD&C Act.
5
Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

Contains Nonbinding Recommendations
“Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical
Devices”. 6
The objectives of this guidance are:
1. To describe the factors FDA will use in determining device type eligibility for review by
3P510k Review Organizations
2. To outline FDA’s process for the recognition, rerecognition, suspension, and withdrawal
of recognition for 3P510k Review Organizations
3. To ensure consistent quality of work among 3P510k Review Organizations through the
Medical Device User Fee Amendments (MDUFA) IV commitments authorized under
FDARA 7 to eliminate the need for routine, substantive re-review by FDA. 8
FDA's guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances 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 means that something is suggested or
recommended, but not required.

II. Background
Basis for 3P510k Review Program
On August 1, 1996, FDA launched a voluntary third party 510(k) review pilot program for
selected medical devices. Under this pilot program, all class I devices that were not 510(k)
exempt at that time, and 30 class II devices were eligible for 3P510k review.
On November 21, 1997, the Food and Drug Administration Modernization Act (FDAMA) was
signed into law. Section 210 of FDAMA 9 codified and expanded the pilot program by
establishing section 523 of the FD&C Act.
On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) 10 was
signed into law and required FDA to establish and publish criteria to accredit, reaccredit, and
deny reaccreditation of 3P510k Review Organizations that perform 510(k) reviews of eligible
devices.
On August 18, 2017, FDARA 11 was signed into law and required FDA to issue guidance on the
factors FDA will use in determining whether a class I or class II device type, or subset of such
6

See https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntaryconsensus-standards-premarket-submissions-medical-devices.
7
Pub L. 115-52
8
See Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews. Available at
https://www.fda.gov/media/116168/download.
9
Pub. L. 105-115
10
Pub. L. 112-144
11
Pub. L. 115-52

Contains Nonbinding Recommendations
device types, is eligible for review by 3P510k Review Organizations, including the risk of the
device type and whether the device type is permanently implantable, life sustaining, or life
supporting, and whether there is a detailed public health justification for permitting the review by
an accredited person of such device type. This guidance also addresses several MDUFA IV
commitments by including an early interaction consult policy and clarifying criteria for
rerecognition of 3P510k Review Organizations and the suspension or withdrawal of
recognition. 12

General Overview of 3P510k Review Program
The 3P510k Review Program is intended to support CDRH’s mission to protect and promote
public health by enabling FDA to focus its internal scientific review resources on higher-risk and
complex devices, while maintaining a high degree of confidence in the review of low-tomoderate risk and less complex devices by 3P510k Review Organizations, and to provide
manufacturers of eligible devices a voluntary alternative review process that may yield more
rapid decisions on 510(k)s. See section 523(a)(3) of the FD&C Act. Figure 1 below provides a
schematic overview of the 3P510k Review Program. 13
Figure 1 – A General Overview of the 3P510k Review Program
510(k) Submitter
sends submission to
3P510k Review
Organization
3P510k Review
Organization
reviews
submission

3P510k Review
Organization
submits
recommendation &
documentation to
FDA

FDA reviews
recommendation
and makes final
decision

FDA informs
3P510k Review
Organization of
final decision

3P510k Review
Organization
informs 510(k)
Submitter of final
decision

Submission
review is
complete

End

Under the 3P510k Review Program, 3P510k Review Organizations review a 510(k) submission
and then forward their review, the 510(k) submission, and a recommendation (e.g., substantially
equivalent (SE) or not substantially equivalent (NSE)) to FDA. FDA reviews the 3P510k Review
Organization’s memo and recommendation and makes a final decision on the submission.
Section 523(a)(2) of the FD&C Act requires FDA to make a determination with respect to the
initial classification within 30 calendar days 14 after receiving a recommendation from a 3P510k
Review Organization. The 510(k) Submitter pays the 3P510k Review Organization directly; no
user fee is due to FDA for the 510(k) reviewed by the 3P510k Review Organization. 15 A general
principle of the 3P510k Review Program is that the 3P510k Review Organization is the conduit
for communication to and from the 510(k) Submitter and to and from the FDA. This ensures the
12

Through the MDUFA IV Commitment Letter, FDA commits to improving the 3P Review Program with a goal of
eliminating routine re-review by FDA of 3P510k reviews: 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.
13
Figure 1 uses IEC/IEC 19510: Information technology – Object Management Group Business Process Model and
Notation (2013).
14
FDA uses calendar days when measuring on-time performance of user-fee supported premarket medical device
submission reviews. See, “MDUFA Performance Goals and Procedures, Fiscal Years 2018 through 2022” at
https://www.fda.gov/media/102699/download for more information.
15
See Section 738(a)(2)(B) of the FD&C Act.

Contains Nonbinding Recommendations
3P510k Review Organization is fully informed and that communications do not undermine their
role.
A 3P510k Review Organization must be recognized by FDA under section 523(b) of the FD&C
Act to be eligible to participate in the 3P510k Review Program. FDA recognizes 3P510k Review
Organizations 16 to review 510(k)s for certain device types eligible for the 3P510k Review
Program. 17
Participation by 510(k) Submitters in the 3P510k Review Program is entirely voluntary.
Manufacturers who do not wish to use a 3P510k Review Organization may submit their 510(k)s
directly to the FDA for review, through either the Traditional, Special, or Abbreviated Programs,
as appropriate. 18, 19, 20
As described in this guidance, the 3P510k Review Program includes features designed to ensure
a high level of quality in the review of 510(k)s by a 3P510k Review Organization and to
minimize risks to public health. In evaluating a 3P510k Review Organization for recognition or
rerecognition, FDA will consider the application, as outlined in Section VIII of this guidance,
provided by a 3P510k Review Organization. In addition, FDA may consider past premarket
review performance of the 3P510k Review Organization as described in Section VIII.B. 21

III. Scope
This guidance outlines FDA’s current thinking on key aspects of the 3P510k Review Program,
including:
1. FDA’s expectations for 3P510k Review Organization reviews of 510(k) submissions,
including the policy for early interaction consults (see Section VI)
2. Factors used to establish device type eligibility in the 3P510k Review Program (see
Section V)
3. Requirements and recommendations for recognition and rerecognition of 3P510k Review
Organizations under the 3P510k Review Program (see Section VII)
4. Content and format of a 3P510k Review Organization’s application for initial recognition
and rerecognition (see Section VIII)
5. Process for suspension or withdrawal of recognition (see Section IX)

For a current list of recognized 3P Review Organizations under the 3P Review Program, please visit FDA’s
website at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/Accredit.cfm.
17
For a current list of eligible devices for 3P review under the 3P Review Program, please visit FDA’s website at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm
18
The guidance document describing the 510(k) Program is available on FDA’s website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantialequivalence-premarket-notifications-510k.
19
The guidance document for the Abbreviated 510(k) Program is available on FDA’s website
athttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/abbreviated-510k-program.
20
The guidance document for the Special 510(k) Program is available on FDA’s website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-510k-program.
21
See section 523(b)(2) and section 523(b)(3) of the FD&C Act.

Contains Nonbinding Recommendations
6. Leveraging the International Medical Device Regulators Forum’s (IMDRF’s)
requirements for Regulatory Reviewers under the Good Regulatory Review Practices
(GRRP) and the Medical Device Single Audit Program (MDSAP), as appropriate (see
Section X)
Currently accredited 3P510k Review Organizations should submit their application materials for
recognition in the manner described in SectionVIII of this guidance within six months of the
publication date of this guidance.

IV. Definitions
The definitions provided below explain the terms used by FDA in the context of this guidance.
These terms are not intended to be applied in any context beyond this document and the 3P510k
Review Program.
Device Type: A device type or category as set forth in a section of the Code of Federal
Regulations, as well as a subset of such device type, such as that set forth in a product code.
510(k) Submitter: An entity or person that submits a 510(k) submission to a 3P510k Review
Organization for the purposes of demonstrating substantial equivalence (SE) of that device to a
legally marketed device that is not subject to premarket approval (PMA).
Final Reviewer: An individual within the 3P510k Review Organization who oversees the
review of a 510(k) submission throughout the entire review process. The Final Reviewer is a
regulatory reviewer who meets the criteria of an IMDRF Regulatory Reviewer (defined below)
and who is responsible for ensuring that final recommendations regarding the device made by the
Product Specialist (defined separately) are appropriately evaluated, organized, and documented
before documents are sent to FDA. This individual has sufficient authority and competence
within the 3P510k Review Organization to independently evaluate the quality and acceptability
of the 3P510k review documentation. The Final Reviewer is a separate individual from the
Product Specialist.
IMDRF: International Medical Device Regulators Forum
IMDRF MDSAP Document: IMDRF MDSAP WG/N3 FINAL: 2016 (Edition 2) –
“Requirements for Medical Device Auditing Organizations for Regulatory Authority
Recognition” 22 produced by the International Medical Device Regulators Forum (IMDRF)
intended to implement the concept of a Medical Device Single Audit Program (MDSAP). 23 This
document provides criteria for audit programs that FDA believes 3P510k Review Organizations
should follow, where applicable, and to the extent such criteria are appropriate and consistent
with the FD&C Act and other applicable laws and regulations.

Contains Nonbinding Recommendations
IMDRF Medical Device Single Audit Program: An international program, established by
IMDRF, specifying a standard set of requirements for the recognition of auditing organizations
performing regulatory audits of medical device manufacturers and other related functions.
IMDRF Regulatory Reviewer: An individual meeting and fulfilling the competencies,
commitments, training, and conduct described in IMDRF/GRRP WG/N40 FINAL:2017 –
“Competence, Training, and Conduct Requirements for Regulatory Reviewers” 24 produced by
the International Medical Device Regulators Forum (IMDRF). This is IMDRF’s Good
Regulatory Review Practices (GRRP) document describing criteria “for individuals who perform
regulatory reviews of medical devices for marketing authorization,” whether those individuals
work for governmental regulatory authorities or Conformity Assessment Bodies (CABs) 25 that
FDA believes 3P510k Review Organizations should follow, where applicable, and to the extent
such criteria are appropriate and consistent with the FD&C Act and other applicable laws and
regulations.
Product Specialist: An individual within the 3P510k Review Organization, who meets the
criteria of an IMDRF Regulatory Reviewer (defined above), and is qualified to review and
evaluate medical devices within specific device type(s), who may also be qualified for a specific
technical or clinical specialization (e.g., biocompatibility and Ethylene Oxide (EtO)
sterilization), based on their scientific background and competence. This individual is the
primary reviewer responsible for leading the 3P510k Review Organization’s review team on a
given 510(k) submission. The Product Specialist submits their recommendation and all related
documentation to the Final Reviewer.
Recognition: The process of accrediting 3P510k Review Organizations under section 523 of the
FD&C Act to review premarket notifications submitted under section 510(k) of the FD&C Act of
certain eligible devices and make recommendations to FDA regarding the initial classification of
such devices under section 513(f)(1) of the FD&C Act.
Rerecognition: The process of renewing the accreditation of 3P510k Review Organizations
under section 523 of the FD&C Act for an additional three years.
Recognition Criteria: The applicable FD&C Act requirements, including the qualification
requirements set forth in section 523(b)(3); FDA’s recommendations described in this guidance
document, including those criteria contained in IMDRF MDSAP WG N3 26, (which include the
International Organization for Standardization (ISO)/the International Electrotechnical
Commission (IEC) 17021:2011 “Conformity assessment – Requirements for bodies providing
audit and certification of management systems”, where appropriate and applicable) and IMDRF
24

IMDRF/GRRP WG/N40 Final:2017: “Competence, Training, and Conduct
Requirements for Regulatory Reviewers” can be found at http://www.imdrf.org/docs/imdrf/final/technical/imdrftech-170316-competence-conduct-reviewers.pdf.
25
“Conformity Assessment Body (CAB): A body other than a Regulatory Authority engaged in determing whether
the relevant requirements in technical regulations or standards are fulfilled (GHTF/SG1/N78:2012)”, IMDRF/GRRP
WG/N40FINAL:2017, section 3.6.
26
IMDRF MDSAP Working Group N3 Final: 2016 (Edition 2): “Requirements for Medical Device Auditing
Organizations for Regulatory Authority Recognition”, previously cited, can be found at
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-160324-requirements-auditing-orar.pdf.

Contains Nonbinding Recommendations
GRRP WG N40 27; and the criteria to accredit or deny accreditation announced in the Federal
Register. 28
Recognition Denial: The process of denying an application for accreditation submitted by a
potential 3P510k Review Organization.
Rerecognition Denial: The process of denying an application for reaccreditation submitted by a
recognized 3P510k Review Organization.
Recognition Withdrawal: The process of withdrawing or suspending accreditation of a 3P510k
Review Organization in accordance with section 523(b)(2) of the FD&C Act.
Safety Signal: A signal represents a new potentially causal association or a new aspect of a
known association between a medical device and an adverse event or set of adverse events. 29
Technical Expert: An individual who provides specific knowledge or expertise. This
individual may be an employee of a 3P510k Review Organization or may be external as
described below in Sections VI.B and VII.D of this guidance, respectively.
Third Party (3P510k) Review Organization: An organization recognized by FDA to review
510(k) submissions for certain eligible devices as authorized by section 523 of the FD&C Act.

V. Factors Used in Determining Device Type Eligibility in
the 3P510k Review Program
The factors FDA will consider in determining device type eligibility for the 3P510k Review
Program are as follows:
1. The risk of the device type, or subset of such device type. 30 FDA generally classifies

medical devices based on risks associated with the device type and whether general
controls are sufficient to provide a reasonable assurance of the safety and effectiveness of
the device or there is sufficient information to establish special controls to mitigate such
risks and provide such assurance. Devices are classified into one of three regulatory
classes: class I, class II, or class III. 31 In accordance with the statute, class III devices are
not eligible for 3P510k review. 32

IMDRF/GRRP WG/N40 Final:2017: “Competence, Training, and Conduct
Requirements for Regulatory Reviewers”, previously cited, can be found at
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-competence-conduct-reviewers.pdf.
28
63 FR 28388 (May 22, 1998) is available at https://www.gpo.gov/fdsys/pkg/FR-1998-05-22/pdf/98-13799.pdf.
29
See Signal Management Program in “Medical Device Safety Action Plan: Protecting Patients, Promoting Public
Health” at https://www.fda.gov/media/112497/download.
30
See section 523(a)(3)(B)(i)(I) of the FD&C Act.
31
For more information on the classification of medical devices, please visit FDA’s website at
https://www.fda.gov/about-fda/cdrh-transparency/overview-medical-device-classification-and-reclassification.
32
See section 523(a)(3)(A)(i) of the FD&C Act.

Contains Nonbinding Recommendations
2. Whether the device type, or subset of such device type, is intended to be permanently
implanted in the human body, to sustain human life, or to support human life. Any
3P510k Review Organization seeking recognition for review of such device types must
provide a detailed public health justification explaining why this device type should be
eligible for 3P510k review 33 and how this will positively impact public health.
3. The extent to which the device type is well understood. For example, devices with novel
technological characteristics, including some devices requiring complex special controls
initially classified through the De Novo process may be ineligible for 3P510k review. 34
4. The extent to which necessary information to make a well-informed recommendation is
available to 3P510k Review Organizations. If information materially relevant to
evaluating a device type cannot be shared outside the agency (e.g., it is proprietary), the
device type may be ineligible for 3P510k review.
5. The extent to which the review of the device type does not require multifaceted,
interdisciplinary expertise. The following are examples of scenarios that would likely be
ineligible for 3P510k review due to the need for such expertise:
a. the review of some kinds of clinical data or complex non-clinical data (e.g.,
computational modeling);
b. a need for consultation across different FDA organizational components, or in
cross-modality topics (e.g., a multi-reader clinical study);
c. a combination product or device type either of which requires review from
another Center in the Agency; 35
d. if a device type raises novel cross-labeling considerations, such as the potential
for off-label use of drugs (e.g., injector needles or syringes). “Cross-labeled”
products usually refer to any drug, device, or biological product packaged
separately that, according to its proposed labeling, is for use only with another
individually specified drug, device, or biological product where both are required
to achieve the intended use, indication, or effect. 36
However, if a device type contains simple clinical data such as sample clinical images or
tests using banked specimens, it may be eligible for 3P510k review. Most in vitro
diagnostic (IVD) devices are eligible for 3P510k review as they typically rely on simple
clinical studies to demonstrate SE, provided that such devices also meet the other factors
listed in this section.
33

See section 523(a)(3)(B)(i)(II) of the FD&C Act.
The guidance document describing the De Novo process is available on FDA’s website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/de-novo-classification-processevaluation-automatic-class-iii-designation.
35
For more information on combination products, please visit FDA’s website at https://www.fda.gov/combinationproducts/about-combination-products/frequently-asked-questions-about-combination-products.
36
For more information on cross-labeling and diagnostic devices, see the guidance “In Vitro Companion Diagnostic
Devices” available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/vitro-companiondiagnostic-devices.
34

Contains Nonbinding Recommendations

6. The availability of postmarket data suggesting that the device type is the subject of safety
signals. For example, if a device type is the subject of a safety communication, a highrisk recall (Class I) 37, or postmarket data that indicate a safety signal, this device type
may be ineligible for 3P510k review.
For example, as of the date of issuance of this guidance, duodenoscopes have a safety
signal associated with their reprocessing. 38 Because of this safety signal, FDA may
remove duodenoscopes and accessories from eligibility for the 3P510k Review Program.
FDA will consider each of the above factors in determining device type eligibility for 3P510k
review. Furthermore, if a device type is considered eligible for 3P510k review, but a proposed
modification to the device type for a specific submission raises different concerns related to the
factors listed above, that submission may be determined to be ineligible for 3P510k review.
The product code classification database 39 and FDA’s list of devices eligible for 3P510k
review 40 has been updated to reflect these eligibility factors to determine 3P510k eligibility for
device types. If eligible device types are determined to be ineligible for 3P510k review, or
ineligible ones are determined to be eligible for 3P510k review, FDA will change their status in
the database and FDA’s publicly-available list. FDA will periodically review new device types
using the factors described above to determine whether they are appropriate for 3P510k review,
and update the database and list accordingly.

VI. Review of 510(k) Submissions by 3P510k Review
Organizations
FDA believes that 3P510k Review Organizations should conduct FDA-equivalent reviews of
eligible devices. 3P510k Review Organizations are responsible for reviewing and analyzing
scientific and technical data in a 510(k) submission to make a recommendation regarding the
device to the FDA. 3P510k Review Organizations should conduct their review of 510(k)s in the
manner described in the sections below and in accordance with their own quality control
practices. Figure 2 identifies the key steps in a 3P510k Review Organization’s review of a 510(k)
submission. 41
37

For information on classification of recalls, please visit FDA’s website at https://www.fda.gov/medicaldevices/postmarket-requirements-devices/recalls-corrections-and-removals-devices.
38
Information on safety signals associated with duodenoscopes is available on FDA’s website at
https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infections-associated-reprocessedduodenoscope.s
39
The product code classification database is available on FDA’s website at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.
40
For a current list of eligible devices for 3P review under the 3P Review Program, please visit FDA’s website at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm.
41
Figure 2 uses IEC/IEC 19510: Information technology – Object Management Group Business Process Model and
Notation (2013).

Contains Nonbinding Recommendations

Figure 2: Steps in a 3P510k Review Organization’s 510(k) Review
3P510k Review
Organization
receives
submission from
510(k) Submitter

3P510k Review
Organization
refuses to accept
file for review

Section VI.A.

Determine
Device
Eligibility

Is the
device
eligible?

Section VI.F.

Section VI.G.

Conduct &
document
substantive
review

Yes

Is additional No
info needed?
Yes

Receive additional
Request additional
information
information
from 510(k) submitter from 510(k) submitter

Section VI.D.

Section VI.B.

Section VI.C.

Assign a Product
Specialist and if
necessary, a
Technical Expert

Obtain
guidance and
relevant
information

Section VI.H.

Section VI.I.

Document the
review

Organize
submission
including
3P510k
documentation

Obtain early
interaction
consult
(as needed)
Section VI.E.

Ensure
submission is
complete

Final End
Reviewer
submits
recommendation
and submission
to FDA

Determine device eligibility for 3P510k review
Before reviewing a 510(k) submission, a 3P510k Review Organization should determine whether
it has the expertise to review the device type and whether that device type is eligible for 3P510k
review based on review of the product code classification database 42 or the FDA Third Party
Review public website. 43 If the 3P510k Review Organization lacks the expertise or the device is
not eligible for 3P510k review, the 3P510k Review Organization should not accept the 510(k)
for review from the 510(k) Submitter. If the 3P510k Review Organization determines the device
is ineligible for 3P510k review after it has already accepted the 510(k) submission, the 3P510k
Review Organization should immediately inform the 510(k) Submitter and discontinue the
review.
If the 3P510k Review Organization submits a 510(k) submission to FDA for an ineligible device,
or a device the 3P510k Review Organization is not recognized to review (see Section VIII.A),
FDA will place the submission on hold and notify the 3P510k Review Organization of FDA’s
eligibility assessment. Unless the 3P510k organization intends to address the eligibility concerns,
it should promptly consult with the 510(k) Submitter and, if the 510(k) Submitter concurs,
promptly send a 510(k) withdrawal request to FDA. If the 3P510k Review Organization does not
address eligibility concerns or withdraw the submission within 180 days, FDA will delete the
file. A 510(k) Submitter cannot submit a 510(k) for the same device directly to FDA until the file
42

The product code classification database is available on FDA’s website at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.
43
For a list of eligible devices for 3P review under the Third Party Review Program, please visit FDA’s website at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm.

Contains Nonbinding Recommendations
is withdrawn voluntarily by the 3P510k Review Organization or deleted automatically by FDA
after 180 days. If a 3P510k Review Organization is unclear regarding the eligibility status of a
device, it should contact the 3P510k inbox at [email protected] to seek clarification.

Assign a Product Specialist(s) and Technical Expert(s) to
conduct the substantive review of a 510(k) submission
3P510k Review Organization personnel should have appropriate education, training, skills,
technical knowledge, qualifications, and experience to perform 510(k) reviews for the device
type(s) their organization is recognized to review. For additional discussion on FDA’s
recommendations regarding qualifications of personnel, see Section VII.C of this guidance.
Each 510(k) submission should be assigned to a Product Specialist with appropriate expertise for
the type of device under review. The Product Specialist may add qualified Technical Experts to
the review team to ensure sufficient competency in the review, if necessary. The Product
Specialist should document the competencies of, and the rationale for, choosing to use any
Technical Experts. Particular attention should be given to the expertise and impartiality of any
external Technical Experts. For more information on using external Technical Experts, please
see Section VII.D of this guidance.

Obtain relevant FDA guidance(s) and information
3P510k Review Organizations should review and be familiar with publicly available information
relevant to their review. For example:
1. 3P510k Review Organizations should review FDA’s guidance database to obtain any
relevant final guidance documents 44 when conducting their reviews, including devicespecific and horizontal guidances (e.g., biocompatibility, software, sterility).
In addition, 3P510k Review Organizations should be aware of any special controls,
which are regulatory requirements for certain class II devices, that apply to that device
type under review. For information on whether a device type has applicable special
controls, 3P510k Review Organizations should review the proposed classification
regulation of the device under Title 21 of the Code of Federal Regulations (CFR), 45
which will identify the mandatory special controls for a particular device type.

The guidance database search engine allows users to search the inventory of guidances available by title, words,
or origin and is available on FDA’s website at https://www.fda.gov/regulatory-information/search-fda-guidancedocuments
45
The Code of Federal Regulations Title 21 database is available at https://www.ecfr.gov/cgibin/ECFR?page=browse

Contains Nonbinding Recommendations
2. 3P510k Review Organizations should review FDA’s postmarket databases, including
recalls, market withdrawals, and safety reports; 46 Medical Device Reports; 47 and MedSun
Reports 48 for the predicate device and/or the device type to identify any issues with
clinical use of similar devices that should be considered and addressed in the review of
the subject device. If potential safety signals are identified by a 3P510k Review
Organization, it should contact FDA for information on current review practice (see
SectionVI.D below).
3. 3P510k Review Organizations should review publicly available premarket review
information in FDA’s 510(k) database for information about the legally marketed device
(‘predicate’) to which a Submitter is comparing its device, or other similar devices, 49
including Indications for Use Statements, 510(k) Summaries, 50,51 Decision Summaries (if
available), and FDA decision letters. In some instances, a device’s product code can also
be used to identify a generic category of a device and assist with the identification of
similar devices. Product codes can be found in FDA’s product code database. 52
4. If an applicant wishes to utilize standards, the 3P510k Review Organization should
review FDA’s guidance document entitled “Appropriate Use of Voluntary Consensus
Standards in Premarket Submissions for Medical Devices.” 53
3P510k Review Organizations should request that 510(k) Submitters fully inform them of any
prior communications with FDA about a device under review, including but not limited to FDA
feedback obtained through the Q-Submission program, unsuccessful marketing applications, and
other interactions. If applicable, 3P510k Review Organizations should be familiar with the FDA
Q-Submission Program, including the Pre-Submission process, through the guidance document
entitled, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-

The recalls database allows users to search for recalls and correction or removal actions initiated by a firm prior to
recall classification and is available on FDA’s website at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm.
47
The MAUDE database allows users to search for Medical Device Reports and is available on FDA’s website at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm.
48
The MedSun database allows users to search for adverse event reports from the Medical Product Safety Network
and is available on FDA’s website at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/searchReportText.cfm.
49
The 510(k) database search engine allows users to search all previously cleared 510(k) submissions by 510(k)
number, applicant name, device name, product code, etc., and is available on FDA’s website at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.
50
510(k) Summaries should be written in accordance with 21 CFR 807.92 and is available at
https://www.ecfr.gov/cgi-bin/textidx?SID=7272ad96195b5a401402c8b22c785d10&mc=true&node=se21.8.807_192&rgn=div8.
51
The guidance document describing 510(k) Summaries is available on FDA’s website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantialequivalence-premarket-notifications-510k.
52
The product code database is available on FDA’s website at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.
53
The guidance document describing the use of standards to determine substantial equivalence is available on
FDA’s website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-usevoluntary-consensus-standards-premarket-submissions-medical-devices.

Contains Nonbinding Recommendations
Submission Program. 54 A 3P510k Review Organization should request that the authorization
letter from the 510(k) Submitter grant FDA permission to discuss previous submissions,
identified by submission numbers, with the 3P510k Review Organization (see Section VI. I). If
applicable, the 3P510k Review Organization should coordinate with the 510(k) Submitter to
obtain and review prior submission content for the device, any written feedback or meeting
minutes resulting from prior interactions, and any additional data, studies and/or study protocols
submitted in response to previous submissions by the 510(k) Submitter prior to submitting the
current submission to FDA.
3P510k Review Organizations should also request that 510(k) Submitters submit only one 510(k)
for a specific device at a time.

Early Interaction with FDA (as needed)
3P510k Review Organizations should interact, as needed, with appropriate FDA staff prior to,
and during the review of, 510(k) submissions. Early interactions – those between the 3P510k
Review organization and FDA prior to the substantive review – can be an important part of the
510(k) review process (for potential topics, refer to section VI.C). These interactions help ensure
timely and consistent 510(k) reviews by assisting in device eligibility determinations and
identifying relevant issues and contemporary review criteria.
In their initial recognition applications, 3P510k Review Organizations commit to early
interaction with FDA before reviewing a device type they have not previously reviewed (see
Section VIII.A). This ensures the 3P510k Review Organization has the latest FDA thinking on
relevant guidance, standards, and other considerations for that device type. FDA also encourages
early interaction for all 3P510k submissions, particularly for the first review of any device type
by an individual Product Specialist and for any subset of device type (i.e., device type by product
code) they have not recently reviewed. Generally, FDA considers a recent review to be within
the last six months.
Procedures on how to obtain early interaction will be available on the FDA Third Party public
website. FDA intends to respond to 3P510k Review Organization requests within 2 business
days. If that deadline cannot be met, FDA will work with the 3P510k Review Organization to
establish a reasonable timeline for a response.

Ensure a submission is administratively complete
To ensure that a submission is administratively complete, 3P510k Review Organizations should
conduct an acceptance review of the 510(k) submission based on 510(k) regulations from 21
CFR 807.87 to 807.100 to assess whether the 510(k) submission includes all the information
necessary to conduct a substantive review and to reach a recommendation (e.g., SE or NSE) as
defined under section 513(i) of the FD&C Act to submit to FDA. FDA recommends that 3P510k
54

The guidance document describing the Q-Submission program is available on FDA’s website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetingsmedical-device-submissions-q-submission-program.

Contains Nonbinding Recommendations
Review Organizations use the Refuse to Accept (RTA) checklist for 510(k) submissions to make
the determination regarding whether a submission is administratively complete. For more
information on the RTA checklist, please see FDA’s guidance document entitled “Refuse to
Accept Policy for 510(k)s.” 55
3P510k Review Organizations should not act as a consultant for the 510(k) Submitter. It is the
responsibility of the 510(k) Submitter to be familiar with the content and format requirements of
a 510(k) prior to submitting to a 3P510k Review Organization. If a Submitter is not familiar with
the 510(k) regulatory pathway, 3P510k Review Organizations should direct them to resources
such as FDA’s guidance documents entitled, “The 510(k) Program: Evaluating Substantial
Equivalence in Premarket Notifications [510(k)]”, 56
“The Abbreviated 510(k) Program”, 57 “The Special 510(k) Program”, 58 or the Division of
Industry and Consumer Education in the Office of Communication and Education. 59
If the 3P510k Review Organization determines that a submission is administratively complete,
the organization should begin its substantive review of the 510(k) submission. If the 3P510k
Review Organization identifies any deficiencies in the 510(k) submission, it should contact the
510(k) Submitter to request the missing information.

Conduct the substantive review of a 510(k) submission
Substantive review focuses on the evaluation of SE as defined in section 513(i) of the FD&C
Act. 21 CFR 807.100(b) sets forth the criteria that FDA uses to determine whether a device is
substantially equivalent to a legally marketed device. For information on making an SE
determination under the 510(k) program, please see FDA’s guidance document entitled “The
510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” 60

The guidance document for Refuse to Accept policy is available on FDA’s website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks.
56
The guidance document for the 510(k) Program is available on FDA’s website at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarketnotifications-510k.
57
The guidance document for the Abbreviated 510(k) Program is available on FDA’s website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/abbreviated-510k-program.
58
The guidance document for the Special 510(k) Program is available on FDA’s website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-510k-program.
59
The contact information for the Division of Industry and Consumer Education is available on FDA’s website at
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-divisionindustry-and-consumer-education-dice.
60
The guidance document used to determine the substantial equivalence of a device is available on FDA’s website
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluatingsubstantial-equivalence-premarket-notifications-510k.

Contains Nonbinding Recommendations
For information on Abbreviated and Special 510(k)s, see FDA’s guidance documents entitled
“The Abbreviated 510(k) Program” 61 and “The Special 510(k) Program.” 62
3P510k Review Organizations should identify at least one Final Reviewer within its organization
who is independent from prior review of the submission and is responsible for providing a final
supervisory assessment of the Product Specialist’s work before it is submitted to FDA. This
individual should have sufficient authority and competence to independently assess the quality
and acceptability of the Product Specialist’s review of the 510(k) submission.
If 3P510k Review Organizations identify any deficiencies during their substantive review, they
should contact the 510(k) Submitter with a request that the deficiencies be addressed. Section
VI.G below provides further instruction on how to identify deficiencies in a 510(k) submission.
When the substantive review is complete, the Product Specialist(s), Technical Expert(s), if
applicable, and Final Reviewer should reach an agreement on a final recommendation (e.g., SE
or NSE to a predicate device) before submitting the recommendation to FDA.

Identify deficiencies in a 510(k) submission
If a 3P510k Review Organization identifies any deficiencies during their review, it should
contact the 510(k) Submitter. 3P510k Review Organizations may use any form of
communication (i.e., telephone, facsimile, electronic mail, or letter) to resolve the matter
provided confidentiality is maintained and the interaction is documented. 3P510k Review
Organizations should, however, avoid the exchange of substantive data and information solely
over the telephone to avoid errors that may arise in the absence of a written request and response.
As part of providing an FDA-equivalent review, when requesting additional information from a
510(k) Submitter, 3P510k Review Organizations should structure their additional information
requests as described in FDA’s guidance document entitled “Developing and Responding to
Deficiencies in Accordance with Least Burdensome Provisions.” 63 This guidance document has
examples of well-constructed deficiencies and responses to FDA’s requests.
3P510k Review Organizations should document the deficiencies, the 510(k) Submitter’s
response to the deficiencies, and the discussion on the adequacy of the response in the 3P510k
Review Organization’s review memorandum sent to FDA. The review memorandum should also
provide to FDA a copy of all written communications related to resolving the deficiencies
between the 510(k) Submitter and the 3P510k Review Organization (e.g., electronic mail, letters,
summary of teleconferences). If the 510(k) Submitter made any modifications to the submission
in response to a deficiency (e.g., revised 510(k) summary), the 3P510k Review Organization
should document this modification and request that the 510(k) Submitter provide the latest
61

The guidance document for the Abbreviated 510(k) Program is available on FDA’s website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/abbreviated-510k-program.
62
The guidance document for the Special 510(k) Program is available on FDA’s website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-510k-program.
63
The guidance document on developing and responding to deficiencies is available on FDA’s website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/developing-and-respondingdeficiencies-accordance-least-burdensome-provisions.

Contains Nonbinding Recommendations
version of the 510(k) submission prior to the 3P510k Review Organization submitting to FDA.
For example, if the Product Specialist requested an updated device description, the latest version
should be in the 510(k) submission to FDA. However, the original device description and the
deficiency requesting an updated device description should be found in the review memo. This
will ensure that FDA has the correct version of the 510(k) submission on record. Proper
documentation will ensure that the 3P510k Review Organization does not have or appear to have
the role of a consultant.

Document a 510(k) review
Once a 3P510k Review Organization has made a final recommendation, it should prepare their
review documentation specifying the reasoning and steps that led to their final recommendation.
21 CFR 10.70 (“Documentation of significant decisions in administrative file”) provides a
framework that should be utilized by 3P510k Review Organizations. The content of the review
documentation will vary based on the type of 510(k) submission and device. Recommended
review memorandum examples for documentation purposes will be available on the FDA Third
Party public website. 64
If standards are referenced in a submission, FDA recommends 3P510k Review Organizations
discuss in their review memorandum how they were utilized in the 510(k) submission.
Submitters and 3P510k Review Organizations should consult the FDA guidance entitled,
“Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical
Devices” 65 for use of FDA-recognized consensus standards and use of other standards.
In addition to noting whether or not the necessary information required in a 510(k) submission
was included, 66 the review memorandum should also convey how a 3P510k Review
Organization made their recommendation regarding the device. A thorough and substantive
review memorandum should discuss the adequacy of each section of the submission. In general,
FDA believes it will not be sufficient to state that a section of the 510(k) submission or a
response to a deficiency was adequate without providing an explanation of how the 3P510k
Review Organization came to that determination.
To facilitate FDA’s review process, 3P510k Review Organizations should reference sections and
page numbers of the 510(k) submission in their review memorandum where possible. 3P510k
Review Organizations should also clearly document in the review memorandum any
deficiencies, the response to the deficiencies, and the 3P510k Review Organization’s review of
the response as indicated in Section VI.G.
The review memorandum is the only means by which FDA can understand how and why a
3P510k Review Organization recommended a device to be SE (or NSE) to the predicate device.
64

Review examples will be available on FDA’s third party website: https://www.fda.gov/medical-devices/premarketsubmissions/510k-third-party-review-program.
65
The guidance on use of consensus standards is available on FDA’s website at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarketsubmissions-medical-devices.
66
See 21 CFR 807 Subpart E.

Contains Nonbinding Recommendations
Thorough and clear documentation will reduce the need for FDA to re-review the submission
itself and increase the efficiency of FDA’s final review. 67

Organize and submit a 510(k) submission including
associated 3P510k review documentation
Upon completing the review of a 510(k) submission, the Final Reviewer should submit two
separate eCopy documents to FDA’s Document Control Center, 68 the 510(k) submission
generated by the 510(k) Submitter and the 3P510k review documentation generated by the
3P510k Review Organization.
Since there are two distinct parties involved in the generation of a 3P510k submission, the
3P510k Review Organization and the 510(k) Submitter, each is subject to the eCopy
requirements and each must provide their own eCopy and company cover letter with an eCopy
statement and signature (see section 745A(b) of the FD&C Act ). The 510(k) Submitter should
take care to submit the latest version of the 510(k) submission. This version should include any
documents that have been updated in response to deficiencies from the 3P510k Review
Organization. Please refer to FDA’s guidance entitled “eCopy Program for Medical Device
Submissions” 69 for more information on how to submit through the eCopy program.

To facilitate FDA’s review, we recommend that a 3P510k Review Organization’s 510(k)
documentation include the following:
(1) A cover letter signed by the Final Reviewer that clearly identifies:
a. The purpose of the submission
b. The name and address of the 3P510k Review Organization and the contact person
c. The name, email address, and telephone number of the Final Reviewer
d. The name and address of the 510(k) Submitter

Through the MDUFA IV Commitment Letter, FDA commits to improving the 3P Review Program with a goal of
eliminating routine re-review by FDA of 3P reviews: 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. See also “Eliminating Routine FDA Re-Review of Third Party
510(k) Reviews, available at https://www.fda.gov/media/116168/download.
68
The address for CDRH’s Document Control Center is available on FDA’s website at
https://www.fda.gov/medical-devices/how-study-and-market-your-device/ecopy-program-medical-devicesubmissions.
69
The guidance document on eCopies is available on FDA’s website at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/ecopy-program-medical-device-submissions.

Contains Nonbinding Recommendations
e. The name of the device (trade name, common or usual name, FDA classification
regulation name, classification regulation number, and product code, as applicable)
f. The 3P510k Review Organization’s recommendation (SE or NSE) with respect to the
device
g. The date the 3P510k Review Organization first received the 510(k) from the
Submitter
(2) A letter signed by the 510(k) Submitter authorizing the 3P510k Review Organization to
submit the 510(k) to FDA on their behalf and authorizing the 3P510k Review
Organization to discuss the contents of the 510(k) with FDA on their behalf. This letter
should also authorize FDA to discuss other, related submission(s) from the same 510(k)
submitter with the 3P510k Review Organization and should include a list of those
submission numbers.
(3) A signed certification that the reported information accurately reflects the data reviewed
and that no material fact has been omitted. This certification should also state that the
3P510k Review Organization continues to meet personnel qualifications and prevention
of conflicts of interest criteria reviewed by FDA; that the 3P510k Review Organization’s
review is based on the 510(k) that it is submitting with the review; and that the 3P510k
Review Organization understands that the submission of false information to the
government is prohibited by 18 U.S.C. 1001 and 21 U.S.C. 331(q).
(4) A table of contents listing the sections where the 510(k) submission and associated
3P510k review documentation are located, along with the corresponding page numbers.
(5) A summary of any early interaction consults that occurred prior to the 510(k) submission
to FDA with FDA staff, if appropriate (see Section VI.D of this guidance).
(6) The 510(k) Submitter’s complete 510(k) submission that conforms to FDA's
requirements for content and format as provided in 21 CFR part 807 subpart E. The
510(k) submission should be prepared by the 510(k) Submitter, not the 3P510k Review
Organization. This information should be separate from the 3P510k Review
Organization’s documentation and should be the latest version. Please see Section VI.G
for more information. Proper documentation will ensure that the 3P510k Review
Organization does not have or appear to have the role of a consultant.
(7) An acceptance review of the 510(k) submission based on objective criteria using the RTA
checklist, discussed in Section VI.E of this guidance, to assess whether the submission is
administratively complete and includes all of the information necessary for the 3P510k
Review Organization to conduct a substantive review on FDA’s behalf.
(8) A review memorandum including complete documentation of the 3P510k Review
Organization’s review of the 510(k) submission as described in Sections VI.G and VI.H
of this guidance, signed by all personnel who conducted the review (generally the
21

Contains Nonbinding Recommendations
Product Specialist(s), Technical Expert(s), when applicable, and Final Reviewer), with a
decision recommendation.
FDA will begin its review of the 3P510k Review Organization’s recommendation only after it
receives all documentation it believes is needed to conduct its review.

Submit additional information upon FDA’s request
After a 3P510k Review Organization has submitted their 510(k) recommendation, including the
associated 3P510k review documentation, FDA will begin to review the 3P510k review
documentation, and if necessary, the 510(k) submission. If FDA determines that additional
information is needed to make an SE determination, it will contact the 3P510k Review
Organization either by telephone or email. 70 Such requests will describe FDA’s concerns with a
510(k) submission, and identify the information needed to address those concerns.
If FDA places a 510(k) submission “on hold” (i.e., officially suspends review of the submission
pending FDA’s receipt of additional information), it will send an email informing the 3P510k
Review Organization of the “on hold” status and request additional information. For more
information on a request for additional information, please see FDA’s guidance entitled “FDA
and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review
Clock and Goals.” 71
Upon receiving a request from FDA for additional information, the 3P510k Review Organization
should:
(1) Promptly inform the 510(k) Submitter of FDA’s request for additional information
relating to the 510(k) submission and request that the 510(k) Submitter provide responses
to the 3P510k Review Organization in writing.
The 3P510k Review Organization should be involved in any discussions with FDA
regarding the request for additional information, such as if the 510(k) Submitter seeks
clarification or a Submission Issue Meeting 72 with FDA;
(2) Thoroughly review any additional information provided by the 510(k) Submitter to
ensure that it adequately responds to FDA’s concerns;

Through the MDUFA IV Commitment Letter, FDA commits to improving the 3P Review Program with a goal of
eliminating routine re-review by FDA of 3P reviews: 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.
71
The guidance document on FDA review clocks is available on FDA’s website at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/fda-and-industry-actions-premarket-notification-510k-submissionseffect-fda-review-clock-and-goals.
72
Submission Issue Meetings are discussed in the guidance document on the Q-Submission program, available on
FDA’s website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedbackand-meetings-medical-device-submissions-q-submission-program.

Contains Nonbinding Recommendations
(3) Document their review of the response to the deficiency by providing a clear and
thorough assessment of whether and how the response adequately addresses FDA’s
deficiency – this should include updating the review documentation accordingly;
(4) Prepare a cover letter referencing the 510(k) number previously assigned by FDA and
identifying the purpose of the new submission (i.e., response to deficiencies);
(5) Send the cover letter, their additional or revised review documentation, and any
additional information received from the 510(k) Submitter to FDA’s Document Control
Center. 73
The 3P510k Review Organization must provide the two separate eCopy documents 74 (the new
submission eCopy document generated by the 510(k) Submitter and the eCopy document
generated by the 3P510k Review Organization). Each eCopy should be clearly marked as
belonging to the 3P510k Review Organization or the 510(k) Submitter as appropriate. For
information on the eCopy program, see Section VI.I of this guidance.
FDA will begin its review after it receives the 510(k) Submitter’s response to the additional
information request, documentation of the 3P510k Review Organization’s review, and the
3P510k Review Organization’s determination of the adequacy of the response to additional
information requests.

510(k) submission dispute resolution
FDA has developed guidance documents that provide an overview of the appeals processes
available for medical devices (see FDA’s guidances entitled “Center for Devices and
Radiological Health Appeals Processes” 75 and “Center for Devices and Radiological Health
Appeals Processes: Questions and Answers About 517A” 76). The processes for reviewing and
reconsidering FDA decisions or actions on other 510(k) submissions are also available for
3P510k submissions when a dispute between FDA and a 510(k) Submitter arises.
Disputes are often the result of misunderstanding or miscommunication, and FDA encourages
3P510k Review Organizations to seek clarification, as needed, from FDA or the 510(k)
Submitter during a review. If the 510(k) Submitter disagrees with an FDA decision or action, the
3P510k Review Organization should maintain impartiality and exercise care to avoid the
73

The address for CDRH’s Document Control Center is available on FDA’s website on the page describing the
eCopy program at https://www.fda.gov/medical-devices/how-study-and-market-your-device/ecopy-programmedical-device-submissions.
74
The guidance document describing the eCopy Program is available on the FDA’s website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-devicesubmissions.
75
The guidance document describing the CDRH appeals process is available on FDA’s website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-radiological-healthcdrh-appeals-processes.
76
The guidance document on the CDRH appeals process, specifically regarding 517A is available on FDA’s website
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-radiologicalhealth-cdrh-appeals-processes-questions-and-answers-about-517a.

Contains Nonbinding Recommendations
appearance of conflict of interest that may result from acting as an advocate on the 510(k)
Submitter’s behalf.
If a 510(k) Submitter would like to issue a complaint against a 3P510k Review Organization,
communication should be sent to [email protected].

VII. Requirements and Recommendations for Recognition
and Rerecognition of Third Party Review Organizations
In this section of the guidance, FDA describes the criteria considered in recognizing 3P510k
Review Organizations to conduct premarket reviews of eligible 510(k)s as established by
FDASIA.
In accordance with section 523(b)(3) of the FD&C Act, a 3P510k Review Organization shall, at
a minimum, meet the following qualification requirements. Such person:
(1) May not be an employee of the Federal Government
(2) Shall be an independent organization, which is not owned or controlled by a
manufacturer, supplier, or vendor of devices, and which has no organizational, material,
or financial affiliation with such a manufacturer, supplier, or vendor.
(3) Shall be a legally constituted entity permitted to conduct the activities for which it seeks
recognition
(4) Shall not engage in the design, manufacture, promotion, or sale of devices
(5) The operations of such person shall be in accordance with generally accepted
professional and ethical business practices
(6) Shall agree, at a minimum, to include in its request for accreditation a commitment to, at
the time of accreditation, and at any time it is performing any review pursuant to section
523:
a.

Certify that reported information accurately reflects data reviewed

Limit work to that for which competence and capacity are available

c. Treat information received, records, reports, and recommendations as proprietary
information
d. Promptly respond and attempt to resolve complaints regarding its activities for which
it is recognized
e. Protect against the use, in carrying out the review of a 510(k) submission and initial
classification of a device, of any officer or employee of the person who has a
24

Contains Nonbinding Recommendations
financial conflict of interest regarding the device, and annually make available to the
public disclosures of the extent to which the 3P510k Review Organization, and the
officers and employees of the 3P510k Review Organization, have maintained
compliance with requirements relating to financial conflicts of interest
In addition to these minimum requirements set forth in the FD&C Act, a 3P510k Review
Organization should meet additional qualifications announced in the Federal Register. 77 These
qualifications include establishing policies designed to identify, prevent, and ensure reporting to
FDA, of instances where 510(k) Submitters submit substantially the same submission to multiple
3P510k Review Organizations in order to find the one most likely to recommend a substantial
equivalence (SE) determination of the 510(k). Such a practice would undermine the
independence and integrity of the 3P510k Review Program. 78 Other qualifications listed in the
Federal Register or that have been previously identified through guidance are discussed below.

Operational considerations
All submissions and communications with FDA and all documentation pertaining to the review
of a 510(k) submitted to FDA should be in English. For foreign 3P510k Review Organizations, a
United States representative should be designated so that FDA can efficiently communicate with
the 3P510k Review Organization while conducting its review (see Section VIII.A(1)).

Management of impartiality
FDA expects 3P510k Review Organizations to be impartial and free from any commercial,
financial, and other pressures that might present a conflict of interest or an appearance of a
conflict of interest. Therefore, FDA will consider whether the potential 3P510k Review
Organization has established, documented, and executed policies and procedures to prevent any
individual or organizational conflict of interest or the appearance of a conflict of interest,
including conflicts of interests pertaining to their external Technical Experts. Policies and
procedures intended to address this issue should be consistent with IMDRF MDSAP WG/N3
FINAL: 2016 (Edition 2) – “Requirements for Medical Device Auditing Organizations for
Regulatory Authority Recognition” 79 and IMDRF GRRP WG/N40 FINAL:2017 – “Competence,
Training, and Conduct Requirements for Regulatory Reviewers.” 80 For more information on
IMDRF GRRP and MDSAP, see Section X of this guidance below.
FDA recommends that 3P510k Review Organizations also address the following to prevent a
potential conflict of interest:
77

63 FR 28388 (May 22, 1998) is available at https://www.gpo.gov/fdsys/pkg/FR-1998-05-22/pdf/98-13799.pdf.
As noted in 63 FR 28390 (May 22, 1998), available at https://www.gpo.gov/fdsys/pkg/FR-1998-05-22/pdf/9813799.pdf.
79
IMDRF MDSAP Working Group N3 Final: 2016 (Edition 2): “Requirements for Medical Device Auditing
Organizations for Regulatory Authority Recognition”, previously cited, can be found at
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-160324-requirements-auditing-orar.pdf.
80
IMDRF GRRP WG/N40 Final:2017: "Competence, Training, and Conduct
Requirements for Regulatory Reviewers", previously cited, can be found at
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-competence-conduct-reviewers.pdf.
78

Contains Nonbinding Recommendations

(1) 3P510k Review Organizations should not participate in the preparation of 510(k)s if
involved in 510(k) reviews. For more information, see Section VI.E of the guidance.
(2) 3P510k Review Organizations should not task an individual, whether employee or
contractor, with reviewing a 510(k) submission, if that individual was employed
within the last twelve months by that 510(k) Submitter or by a firm who helped
prepare that 510(k) submission. Personnel should not review a medical device that
they developed, helped develop, or prepared for submission.
(3) 3P510k Review Organizations should not promise or advertise any guarantees for
FDA clearance.
Information on the conflict of interest standards FDA applies to its own review personnel is
included in the document entitled “Standards of Ethical Conduct for Employees of the Executive
Branch.” 81 3P510k Review Organizations are encouraged to refer to these standards in
safeguarding their operations against conflicts of interest.
The conflict of interest policies for a 3P510k Review Organization should be fully implemented
and there should be an attestation that those policies have been implemented that is signed by
the most responsible individual at the organization before any 510(k) is accepted for review.
When using external technical experts, see Section VII.D regarding conflicts of interest
safeguards.

Personnel involved in reviewing activities82
FDA expects that 3P510k Review Organizations and their personnel should demonstrate
knowledge and experience with the following, as applicable:
(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)
(2) The Public Health Service Act (42 U.S.C. 201 et seq.)
(3) Regulations in the Code of Federal Regulations implementing these statutes,
particularly 21 CFR Parts 800 through 1299.
Additionally, the 3P510k Review Organization should:
(4) Establish, document, and execute policies and procedures to ensure that 510(k)s are
reviewed by qualified personnel.

81
Standards of Ethical Conduct for Employees of the Executive Branch is available at:
https://www.oge.gov/Web/oge.nsf/0/076ABBBFC3B026A785257F14006929A2/$FILE/SOC%20as%20of%2081%
20FR%2081641%20FINAL.pdf.
82
Additional information on the criteria for personnel qualifications is available in the Federal Register notice
published on 63 FR 28388 (May 22, 1998) at https://www.gpo.gov/fdsys/pkg/FR-1998-05-22/pdf/98-13799.pdf.

Contains Nonbinding Recommendations
(5) Maintain records on the relevant education, training, skills, and experience of all
personnel who contribute to the technical review of a 510(k).
(6) Make available to its personnel clear written instructions for duties and
responsibilities with respect to 510(k) reviews.
(7) Employ personnel who are qualified in all the scientific disciplines relevant to the
510(k)s that the 3P510k Review Organization accepts for review.
(8) Identify at least one individual who is responsible for providing supervision over
510(k) reviews and who has sufficient authority and competence to assess the quality
and acceptability of these reviews.
In addressing the items enumerated above in this section, 3P510k Review Organizations should
be consistent with IMDRF MDSAP WG/N3 FINAL: 2016 (Edition 2) – “Requirements for
Medical Device Auditing Organizations for Regulatory Authority Recognition” 83, including, but
not limited to, maintaining a quality management system, and
IMDRF GRRP WG/N40 FINAL:2017: "Competence, Training, and Conduct
Requirements for Regulatory Reviewers". 84 For more information on IMDRF GRRP and
MDSAP, see Section X of this guidance below.
In addition, 3P510k Review Organizations will be expected to consult national and/or
international standards recognized by FDA as well as FDA guidance documents. 3P510k Review
Organizations should have the capability to interface with FDA’s electronic data systems and
websites through which the 3P510k Review Organization can search for relevant guidance
documents, recognized standards, predicate summaries, and publicly available information
regarding adverse events and recalls when performing premarket review of similar devices.
3P510k Review Organizations must certify in their application that designated personnel will
attend FDA’s training for recognition and rerecognition (see Section VIII.A of this guidance and
the Federal Register notice published on May 22, 1998 (63 FR 28388)). 3P510k Review
Organizations are expected to complete training before conducting any 510(k) reviews under the
program. FDA will not accept 510(k) reviews and recommendations from 3P510k Review
Organizations that have failed to have at least one designated person attend a FDA training
session for recognition.
3P510k Review Organizations should be prepared to conduct technically competent 510(k)
reviews before requesting recognition by FDA. FDA recommends persons involved in a 510(k)
submission review at a 3P510k Review Organization meet the appropriate qualifications (e.g.,
specialized education and experience) provided in this guidance. When a 3P510k Review
Organization requests to expand the scope of device types for which it may review 510(k)
83

IMDRF MDSAP Working Group N3 Final: 2016 (Edition 2): “Requirements for Medical Device Auditing
Organizations for Regulatory Authority Recognition”, previously cited, can be found at
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-160324-requirements-auditing-orar.pdf.
84
IMDRF GRRP WG/N40 FINAL:2017: "Competence, Training, and Conduct
Requirements for Regulatory Reviewers", previously cited, can be found at
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-competence-conduct-reviewers.pdf.

Contains Nonbinding Recommendations
submissions, it should ensure through its policies and procedures in place that its staff are
qualified in the scientific disciplines for the new device types.

Use of external Technical Experts
The following are FDA’s recommendations when 3P510k Review Organizations use an external
Technical Expert:
(1) The 3P510k Review Organization should ensure that external Technical Experts meet
the same standards as those who work within the 3P510k Review Organization, such
as freedom from conflicts of interest;
(2) The 3P510k Review Organization should ensure that external Technical Experts are
discouraged from subcontracting parts of their contract to subcontractors, and if they
do so, then the external Technical Expert should ensure that the subcontractor meets
all requirements applicable to the external Technical Expert.;
(3) 3P510k Review Organizations should maintain records of the qualifications of
external Technical Experts, in addition to evidence of regular monitoring of the
established competence, conflicts of interest and the degree of fulfillment of the
outsourced work
To ensure that 3P510k Review Organizations have sufficient competence among their own staff,
there should be at least one qualified Product Specialist per device type that the 3P510k Review
Organization is recognized to review. This is to ensure that there is not excessive reliance on
external expertise by a 3P510k Review Organization and to enable appropriate oversight of the
qualifications of external Technical Experts by 3P510k Review Organizations.
In addressing the items above, 3P510k Review Organizations should be consistent with IMDRF
MDSAP WG/N3 FINAL: 2016 (Edition 2): “Requirements for Medical Device Auditing
Organizations for Regulatory Authority Recognition” 85 and
IMDRF GRRP WG/N40 FINAL:2017: "Competence, Training, and Conduct
Requirements for Regulatory Reviewers". 86 For more information on IMDRF GRRP and
MDSAP, see Section X of this guidance below.

Confidential information
A 3P510k Review Organization is required to treat information received, records, reports, and
recommendations as proprietary information (see section 523(b)(3)(F)(iii) of the FD&C Act )
and may not disclose confidential commercial information or any trade secret (see section
85

IMDRF MDSAP Working Group N3 Final: 2016 (Edition 2): “Requirements for Medical Device Auditing
Organizations for Regulatory Authority Recognition” can be found at
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-160324-requirements-auditing-orar.pdf.
86
IMDRF GRRP WG/N40 FINAL:2017: "Competence, Training, and Conduct
Requirements for Regulatory Reviewers", previously cited, can be found at
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-competence-conduct-reviewers.pdf.

Contains Nonbinding Recommendations
301(y)(2) of the FD&C Act). Also, in accordance with 21 CFR 807.95, when a 510(k) is
submitted by a device manufacturer to FDA, FDA will not publicly disclose that submission if
certain conditions are met. Thus, a 3P510k Review Organization should not publicly disclose a
510(k) submission for a device that is not currently on the market and where the intent to market
the device has not been disclosed.
FDA will determine whether information submitted to FDA by a 3P510k Review Organization
can be released in accordance with the Trade Secrets Act, Freedom of Information Act, 21 CFR
part 20 and 21 CFR 807.95, regarding confidentiality of information in 510(k)s. In general, as
with 510(k)s submitted directly to FDA, 510(k)s submitted by 3P510k Review Organizations
and associated review documentation will be available for disclosure by FDA after the agency
has issued an SE decision for a device, unless the information is exempt from public disclosure
under 21 CFR part 20 or 21 CFR 807.95. If necessary, a copy of the 510(k) will be provided to
the manufacturer for predisclosure notification according to § 20.61.
In addition, information submitted by a 3P510k Review Organization to obtain recognition or
rerecognition from FDA will be available for disclosure, unless exempted under 21 CFR part 20.

Complaints regarding 510(k) Submitters
The 3P510k Review Organization should send to FDA via e-mail to [email protected]
information on any complaint (e.g., whistleblowing) it receives about a 510(k) Submitter that
could indicate an issue related to the safety or effectiveness of a medical device or a public
health risk.

Third Party Review Organization recordkeeping
Pursuant to section 704(f) of the FD&C Act, a 3P510k Review Organization must maintain
records that support their initial and continuing qualifications to receive FDA recognition. These
records must include the following:
(1) Documentation of the training and qualifications of the 3P510k Review Organization
and its personnel;
(2) The procedures used by the 3P510k Review Organization for handling confidential
information;
(3) The compensation arrangements made by the 3P510k Review Organization; and
(4) The procedures used by the 3P510k Review Organization to identify and avoid
conflicts of interest.
In addition to these recordkeeping requirements, FDA recommends that 3P510k Review
Organizations retain the following records for at least three years (3) following the submission of
a 510(k) for review to FDA:

Contains Nonbinding Recommendations
(1) Copies of all 510(k) reviews and associated correspondence;
(2) Information on the identity and qualifications of all personnel who contributed to the
technical review of each 510(k); and
(3) Other relevant records.
In addressing the items enumerated above, 3P510k Review Organizations should be consistent
with IMDRF MDSAP WG/N3 FINAL: 2016 (Edition 2): “Requirements for Medical Device
Auditing Organizations for Regulatory Authority Recognition” 87, including, but not limited to,
records consistent with their quality management system, and
IMDRF GRRP WG/N40 FINAL:2017: “Competence, Training, and Conduct
Requirements for Regulatory Reviewers.” 88 For more information on the IMDRF documents, see
Section X of this guidance.
In accordance with section 704(f)(1) of the FD&C Act, 3P510k Review Organizations must
make the records specified in that section available upon request by an officer or employee of
FDA. 3P510k Review Organizations shall permit the FDA officer or employee at all reasonable
times to have access to, copy, and/or verify these records. Within 15 days of receipt of a written
request from FDA, 3P510k Review Organizations must make copies of the requested records
available at the place FDA designates (see section 704(f)(2) of the FD&C Act). If FDA’s
monitoring of the 3P510k Review Program, such as a review of compensation arrangements
between 3P510k Review Organizations and 510(k) Submitters, reveals that 510(k) Submitters
are developing business relationships with 3P510k Review Organizations that call into question
the independence or objectivity of a 3P510k Review Organization, FDA will consider limiting a
Submitter's choice of 3P510k Review Organizations. Business relationships that may undermine
the independence or objectivity of a 3P510k Review Organization include, for example,
contracts between a manufacturer and a 3P510k Review Organization that represent a significant
share of the 3P510k Review Organization's income.
Section 523(b)(3)(F)(iv) requires 3P510k Review Organizations to agree that they will promptly
respond and attempt to resolve complaints regarding its activities for which it is accredited. FDA
recommends that 3P510k Review Organizations establish a recordkeeping system for tracking
the submission of those complaints and how those complaints were resolved, or attempted to be
resolved.

VIII.
Content and Format of an Application for Initial
Recognition and Rerecognition as a 3P510k Review
Organization
87

IMDRF MDSAP Working Group N3 Final: 2016 (Edition 2): “Requirements for Medical Device Auditing
Organizations for Regulatory Authority Recognition”, previously cited, can be found at
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-160324-requirements-auditing-orar.pdf.
88
IMDRF GRRP WG/N40 FINAL:2017: "Competence, Training, and Conduct
Requirements for Regulatory Reviewers", previously cited, can be found at
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-competence-conduct-reviewers.pdf.

Contains Nonbinding Recommendations

This section of the guidance provides FDA’s recommendations on what should be included in an
application to FDA for recognition as a 3P510k Review Organization.
The 3P510k Review Organization should inform FDA promptly if they would like to suspend,
withdraw, cancel or reduce the scope of their program. FDA will adjust recognition or
rerecognition as appropriate.

Initial Recognition
Organizations that wish to become recognized as 3P510k Review Organizations under section
523 of the FD&C Act should send their applications to FDA at the following address. To
facilitate review of the application, FDA strongly encourages submission of an eCopy. 89
CDRH Third Party Premarket Review Program
U.S. Food and Drug Administration
Document Control Center (DCC) – WO66-G609
10903 New Hampshire Avenue,
Silver Spring, Maryland 20993 USA.
[email protected]
FDA will acknowledge receipt with an email to the applicant’s designated contact person when
the application is received. FDA will review these materials and respond within 60 calendar
days 90 of the date of the receipt of the application with a decision to recognize or deny
recognition, or a request for additional information. FDA may deem the application incomplete
and deny recognition if the applicant fails to respond to FDA’s request for additional information
in a timely manner.
To facilitate review, the following information should be submitted in an application for FDA’s
consideration:

(1) Administrative information
a. The name and mailing address of the 3P510k Review Organization seeking
recognition;
b. The telephone number, email address, and fax number of the contact person. The
contact person should be the person to whom questions about the content of the
application may be addressed and the person to whom a letter of determination and
general correspondence will be directed. Foreign organizations should also identify
the name, address, telephone number, email address, and fax number of an authorized
89

For information on the eCopy program, please see FDA’s guidance entitled “eCopy Program for Medical Device
Submissions” available on FDA’s website at https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/ecopy-program-medical-device-submissions.
90
FDA uses calendar days when measuring on-time performance of user-fee supported premarket medical device
submission reviews. See, “MDUFA Performance Goals and Procedures, Fiscal Years 2018 through 2022” available
on FDA’s website at https://www.fda.gov/media/102699/download for more information.

Contains Nonbinding Recommendations
representative located within the United States that will serve as the 3P510k Review
Organization’s contact with FDA (see also Section VII.A of this guidance);
c. The name and title of the most responsible individual at the 3P510k Review
Organization;
d. A brief description of the 3P510k Review Organization, including: type of
organization (e.g., not-for-profit institution, commercial business, other type of
organization); size of organization (number of employees); number of years in
operation; nature of work (e.g., testing or certification laboratory); and information
regarding ownership (i.e., name of owner(s) and extent of ownership), operation,
control of organization, and other related information sufficient for FDA to assess its
degree of independence from entities such as device manufacturers and distributors;
e. A listing of any national, state, local, or other recognition; and
f. A list of the device types the applicant seeks to review by product codes or
classification regulation name and regulation. Please refer to the FDA Third Party
public website 91 for devices that are eligible for 3P510k review.

Information on third party eligible device types is available on FDA’s website:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm.

Contains Nonbinding Recommendations

(2) Prevention of conflicts of interest
A copy of the written policies and procedures established by the 3P510k Review Organization to
ensure that the 3P510k Review Organization and its employees, external Technical Experts,
contractors and individual contract employees involved in the evaluation of 510(k)s are free from
conflicts of interest, and to prevent any individual or organizational conflict of interest, or
appearance of conflict of interest that might affect the review process.

(3) Personnel qualifications
A list of personnel who will be involved in the preparation of the 3P510k Review Organization’s
510(k) recommendations, including Product Specialists, Technical Experts, external Technical
Experts, and Final Reviewers. Applicants should demonstrate that these personnel are technically
competent to conduct 510(k) reviews and should document the following in their application:
a. The written policies and procedures established to ensure 510(k)s are reviewed by
qualified personnel;
b. The written instructions for the duties and responsibilities of personnel with
respect to 510(k) reviews;
c. The written personnel standards established to ensure that designated personnel
are qualified in all of the scientific disciplines presented by the 510(k)s for
devices for which the 3P510k Review Organization is applying for its review;
d. The documentation (e.g., curricula vitae or CVs) to establish that the reviewers of
510(k)s (i.e., Product Specialists and Technical Experts) and other involved nonsupervisory personnel meet the Recognition Criteria for qualified personnel. This
includes documentation of education, training, skills, abilities, and experience,
including specialized education and experience needed for the review of devices
for which the 3P510k Review Organization is applying for its review;
e. The documentation (e.g., CVs) to establish that the supervisor(s) of 510(k)
reviewers (i.e., Final Reviewer) have sufficient authority and meet the
Recognition Criteria for qualified supervisory personnel. This includes
documentation of education, training, skills, abilities, and experience, including
specialized education and experience needed for the review of class II devices for
which the 3P510k Review Organization is applying for its review; and
f. A description of the management structure, or, if an external technical expert is
used for 510(k) reviews, the external Technical Expert’s management structure.
The application should describe the position of the individual(s) providing
supervision within the management structure and explain how that structure
provides for the supervision of 510(k) reviewers and other personnel involved in
the review process.
33

Contains Nonbinding Recommendations

(4) Certification statements
As required by statute, and to support FDA’s plan to eliminate routine re-review of 3P510k
submissions, 92 the applicant must provide a statement in their application, signed by the most
responsible individual at the organization, certifying that the 3P510k Review Organization has
committed at the time of accreditation and at any time it is performing any 3P510k review that it:
a. Will report information that accurately reflects data reviewed;
b. Will limit work and reviews to that for which competence and capacity are
available, including conducting 510(k) reviews in accordance with the policies
and procedures it has established regarding review of 510(k)s by qualified
personnel;
c. Will treat any information, records, reports, and recommendations that they may
receive as proprietary and confidential information;
d. Will promptly respond and attempt to resolve complaints regarding the activities
for which it is recognized;
e. Will protect against conflicts of interests in accordance with policies and
procedures it has established relating to prevention of financial conflicts of
interests, and annually make available to the public disclosures of the extent to
which the person, and the officers and employees of the person, have maintained
compliance with requirements relating to financial conflicts of interest;
FDA also encourages the applicant to certify in its application that at all times, it:
a. Will demonstrate conformity while recognized by FDA with the requirements of
section 523 of the FD&C Act;
b. Will maintain records in a manner consistent with Section VII.G of this guidance;
c. Will comply with the eCopy requirements 93 for premarket submissions as
described in the guidance document entitled, “eCopy Program for Medical Device
Submissions,” as discussed in Section VI.I of this guidance;
d. Commits that their most responsible person or designee(s) will have completed
FDA training prior to performing any reviews by the 3P510k Review
Organization, and agrees that their most responsible person or designee(s) will
attend such training when offered and applicable;

See “Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews”, available on FDA’s website at
https://www.fda.gov/media/116168/download.
93
See section 745A(b) of the FD&C Act.

Contains Nonbinding Recommendations
e. Will contact FDA for early interaction before reviewing any subset of device type
(by respective product code) that they have not reviewed as encouraged in Section
VI.D of this guidance; and
f. Will commit to only accepting reviews where the 510(k) Submitters certified that
any relevant prior communications with FDA are disclosed.

Rerecognition
In accordance with section 523(b)(2)(D) of the FD&C Act, a 3P510k Review Organization’s
recognition by FDA will sunset 3 years from the date the recognition was granted under section
523 of the FD&C Act. To continue conducting 3P510k reviews beyond 3 years from the date of
the last recognition or rerecognition, the 3P510k Review Organization must obtain rerecognition.
Requests for rerecognition will be handled in the same manner as initial recognition requests.
Accordingly, rerecognition applications should follow the format described in Section VIII.A of
this guidance. For rerecognition, FDA may also consider the past premarket review performance
of the 3P510k Review Organization and any information that comes to FDA’s attention about the
status of the 3P510k Review Organization’s recognition, including information from an audit. 94
FDA recommends that 3P510k Review Organizations apply for rerecognition a minimum of 60
calendar days before their recognition status expires to prevent any lapse in recognition. A
3P510k Review Organization may request a rerecognition earlier if it so chooses.

Recognition or Rerecognition Denial
A 3P510k Review Organization that wishes to request a reconsideration of a recognition denial
or rerecognition denial may make a written request to FDA. For information about the appeals
processes, please see FDA’s guidance entitled “Center for Devices and Radiological Health
Appeals Processes.” 95 A written appeal should be submitted to the CDRH Ombudsman at:
CDRH Ombudsman
Center for Devices and Radiological Health
Food and Drug Administration
WO32 Room 4282
10903 New Hampshire Avenue
Silver Spring, Maryland 20993 USA

See section 523(b)(2)(C) of the FD&C Act.
Information on the appeals process for CDRH is available on FDA’s website at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/center-devices-and-radiological-health-cdrh-appeals-processes and
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-radiological-healthcdrh-appeals-processes-questions-and-answers-about-517.
95

Contains Nonbinding Recommendations

IX. Suspension or Recognition Withdrawal
Section 523(b)(2)(B) of the FD&C Act authorizes FDA to suspend or withdraw recognition of
any 3P510k Review Organization, after providing notice and an opportunity for an informal
hearing, when the 3P510k Review Organization is substantially not in compliance with the
requirements of section 523 of the FD&C Act, poses a threat to public health or fails to act in a
manner that is consistent with the purposes of section 523 of the FD&C Act.
Under section 301(y)(1) of the FD&C Act, the following actions are prohibited by a 3P510k
Review Organization:
(1) Submission of a report or recommendation that is false or misleading in any material
respect;
(2) Disclosure of confidential information or any trade secrets without the express written
consent of the person who submitted such information or secrets to the 3P510k Review
Organization; and
(3) Receipt of a bribe in any form or doing any corrupt act associated with a responsibility
delegated to the 3P510k Review Organization under the FD&C Act.
FDA will perform an assessment of each 3P510k Review Organization on a periodic (at least
once every three years) 96 or “for cause” basis as part of its auditing to ensure 3P510k Review
Organizations continue to meet the standards of recognition (see section 523(b)(2)(C) of the
FD&C Act). Generally, as resources allow, assessments will involve inspecting a 3P510k
Review Organization’s facility and/or records to ensure that the 3P510k Review Organization is
operating in accordance with the procedures, qualifications, and certifications specified in the
3P510k Review Organization’s application and the FD&C Act.
Furthermore, FDA will periodically evaluate completed premarket reviews of 510(k)s submitted
to FDA under the 3P510k Review Program and will provide feedback to Product Specialists and
the Final Reviewer of 3P510k Review Organizations following its audits.
3P510k Review Organizations should continue to demonstrate technical competency to maintain
recognition. If monitoring of a 3P510k Review Organization reveals nonconformity with section
523, a threat to the public health, or a failure to act in a manner that is consistent with the
purposes of section 523 of the FD&C Act, FDA may take steps to suspend or withdraw
recognition of the 3P510k Review Organization, after providing notice and an opportunity for an
informal hearing. See section 523(b)(2)(B) of the FD&C Act.

See section 523(b)(2)(D)(i) of the FD&C Act.

Contains Nonbinding Recommendations

X. Leveraging the International Medical Device
Regulators Forum’s (IMDRF’s) documents
In February 2011, the IMDRF was convened to discuss future directions in medical device
regulatory harmonization. The IMDRF is a voluntary group of medical device regulators from
around the world, including representatives from the FDA, who collaborate to build on the strong
foundational work of the Global Harmonization Task Force on Medical Devices. The purpose of
the IMDRF is to accelerate international medical device regulatory convergence.
The IMDRF Medical Device Single Audit Program (MDSAP) and Good Regulatory Review
Practices (GRRP) working groups developed documents that provide the fundamental building
blocks of a 3P510k program by providing criteria for reviewer competence, training, and
conduct, and, for organizations, the recognition and monitoring of entities that perform
regulatory audits and other related functions. Details are outlined in a collection of documents
finalized from 2013 through 2019 and available on the IMDRF website. 97
There are many shared elements in FDA’s statutory and regulatory criteria for 3P510k Review
Organizations and IMDRF MDSAP WG/N3 FINAL: 2016 (Edition 2): “Requirements for
Medical Device Auditing Organizations for Regulatory Authority Recognition” 98 and IMDRF
IMDRF GRRP WG/N40 FINAL:2017: “Competence, Training, and Conduct
Requirements for Regulatory Reviewers.” 99 These two documents focus on requirements of an
auditing organization and of individuals performing regulatory reviews and other related
functions under the respective medical device legislation, regulations, and procedures required in
its regulatory jurisdiction.
Due to these similarities, FDA believes that potential 3P510k Review Organizations in
compliance with the GRRP and MDSAP documents, as appropriate, are likely to be in
compliance with most FDA 3P510k Review Organization requirements and meet FDA’s
recommendations outlined in this guidance document. Such organizations do not necessarily
need to generate new documentation for FDA, but rather can leverage existing documents in
their applications to FDA and for ongoing recordkeeping.

As of the publication of this guidance document, the IMDRF has published eight documents related to MDSAP
and three documents related to GRRP. All the IMDRF documents are available on the IMDRF website
at:http://imdrf.org/documents/documents.asp. This guidance references IMDRF GRRP WG N40 Final:2017,
“Competence, Training, and Conduct Requirements for Regulatory Reviewers”, and IMDRF MDSAP WG N3
Final:2016, “Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition.”
98
IMDRF MDSAP Working Group N3 Final: 2016 (Edition 2): “Requirements for Medical Device Auditing
Organizations for Regulatory Authority Recognition”, previously cited, can be found at
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-160324-requirements-auditing-orar.pdf.
99
IMDRF/GRRP WG/N40 FINAL:2017: "Competence, Training, and Conduct
Requirements for Regulatory Reviewers", previously cited, can be found at
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-competence-conduct-reviewers.pdf.

Contains Nonbinding Recommendations

XI. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are subject to review by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520).
The time required to complete this information collection is estimated to be 24 hours to submit
requests for accreditation, 24 hours to submit requests for reacceditation, 40 hours to submit
510(k) reviews by 3P510k Review Organizations to FDA, and 15 minutes to submit complaints
to FDA. In addition, the time required to complete this information collection with respect to
recordkeeping is estimated to be 10 hours for maintaining records of 510(k) reviews and 1 hour
for maintenance of Records regarding qualifications to receive FDA recognition as a 3PRO, and
2 hours for maintenance of a recordkeeping system regarding complaints.
Send comments regarding this burden estimate or suggestions for reducing this burden to:
FDA PRA Staff,
Office of Operations,
Food and Drug Administration,
[email protected]

An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number.
The OMB control number for this information collection is 0910-0375 (To find the
current expiration date, search for this OMB control number available at
https://www.reginfo.gov).

File Type	application/pdf
File Modified	2022-10-25
File Created	2022-10-03