CDRH 513(g) Requests

Contains Nonbinding Recommendations

FDA and Industry Procedures
for Section 513(g) Requests for
Information under the Federal
Food, Drug, and Cosmetic Act
Guidance for Industry and
Food and Drug Administration Staff
Document issued on December 16, 2019.
Document originally issued on December 21, 2015.
This document supersedes, FDA and Industry Procedures for Section 513(g)
Requests for Information under the Federal Food, Drug, and Cosmetic Act,
issued December 21, 2015.
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 0910-0705 (expires 6-30-2021).

See additional PRA statement in Section IX of the guidance.
For questions for the Center for Devices and Radiological Health regarding this document, contact
ORP: Office of Regulatory Programs/Division of Regulatory Programs 1: Submission Support at
301-796-5640. For questions for the Center for Biologics Evaluation and Research regarding this
document contact the Office of Communication, Outreach and Development (OCOD) at 1-800835-4709 or 240-402-8010, or by email at [email protected].

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

Contains Nonbinding Recommendations

Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to
http://www.regulations.gov. Submit written comments to the Division of Dockets Management,
Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.
Identify all comments with the docket number FDA-2010-D-0153. Comments may not be acted
upon by the Agency until the document is next revised or updated.

Additional Copies
CDRH
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
1671 and complete title of the guidance in the request.

CBER
Additional copies are available from the Center for Biologics Evaluation and Research (CBER)
by written request, Office of Communication, Outreach, and Development (OCOD), 10903 New
Hampshire Ave., WO71, Room 3128, Silver Spring, MD 20903, or by calling 1-800-835-4709 or
240-402-8010, by email, [email protected], or from the Internet at
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-informationbiologics/biologics-guidances.

Contains Nonbinding Recommendations

Table of Contents

I.

Introduction............................................................................................................................ 10

II. Statutory Requirements for Device Classification ............................................................... 10
III. Obtaining Information About a Device................................................................................ 12
IV. Submitting a 513(g) Request for Information .................................................................... 14
V. Contents of a 513(g) Request for Information..................................................................... 15
VI. Responding to a 513(g) Request for Information in CDRH or CBER .............................. 17
VII. Paperwork Reduction Act of 1995 ........................................................................................ 18

Contains Nonbinding Recommendations

FDA and Industry Procedures for
Section 513(g) Requests for
Information under the Federal
Food, Drug, and Cosmetic Act
Guidance for Industry and
Food and Drug Administration
Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA
or Agency) on this topic. It does not establish any rights for any person and is not binding
on FDA or the public. You can use an alternative approach if it satisfies the requirements of
the applicable statutes and regulations. To discuss an alternative approach, contact the FDA
staff or Office responsible for this guidance as listed on the title page.

I.

Introduction

The purpose of this guidance is to establish procedures for submitting, reviewing and
responding to requests for information regarding the class in which a device has been
classified or the requirements applicable to a device under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) that are submitted in accordance with section 513(g) of
the FD&C Act, 21 U.S.C. 360c(g).
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.

Statutory Requirements for Device Classification

Section 513(a) of the FD&C Act (21 U.S.C. 360c(a)) establishes three classes of devices
based on the regulatory controls needed to provide reasonable assurance of their safety and
effectiveness: class I (general controls), class II (special controls in addition to general
controls), and class III (premarket approval in addition to general controls).
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Under section 513(f) of the FD&C Act (21 U.S.C. 360c(f)), post-amendments devices
(devices that were not in commercial distribution before May 28, 1976, the date the Medical
Device Amendments were enacted) are classified in Class III. However, FDA may reclassify
a post- amendments device (as Class I or II) or determine that such a device is "substantially
equivalent" (SE) 1 to either another post-amendments device that has been classified into Class
I or II or to a pre-amendments device for which premarket approval is not required. 2 Thus, a
post-amendments device may be subject to regulation as a Class I or II device in certain
circumstances, including when:
• the device is within a type of device that has been classified into class I or II and FDA
has found the device to be SE to a device within such type;
• the device is within a type of pre-amendments device which is to be classified under
section 513(b) of the FD&C Act (21 U.S.C. 360c(b)) and FDA has found the device to
be SE to a device within such type (an unclassified device type); or
• FDA has classified or reclassified the device type in class I or II in accordance with
sections 513(f)(2) or 513(f)(3) of the FD&C Act (21 U.S.C. 360c(f)(2), (3)).
Pursuant to section 513(d) of the FD&C Act (21 U.S.C. 360c(d)), FDA promulgates
classification regulations classifying devices by generic type. A "generic type of device" is "a
grouping of devices that do not differ significantly in purpose, design, materials, energy
source, function, or any other feature related to safety and effectiveness, and for which similar
regulatory controls are sufficient to provide reasonable assurance of safety and effectiveness."
(See 21 CFR 860.3(i)). FDA has issued regulations classifying the vast majority of preamendments devices (devices that were in commercial distribution before May 28, 1976) by
generic type of device. See 21 CFR 860.84. Each classification regulation, located at 21 CFR
parts 862-892, indicates in which class (I, II, or III) FDA has classified the device type. While
the great majority of device classifications codified in 21 CFR parts 862-892 are of preamendments devices, some of these classifications are of post- amendments devices.

1

Substantial equivalence is defined at section 513(i) of the FD&C Act (21 U.S.C. 360c(i)). FDA generally
evaluates substantial equivalence on the basis of a premarket notification submitted pursuant to section 510(k) of
the FD&C Act (21 U.S.C. 360(k)). Certain devices are subject to a statutory exemption from the 510(k) premarket
notification requirement (see sections 510(l) and (m) of the FD&C Act).
2
A pre-amendments device for which premarket approval is not required could be a pre-amendments device that
has been classified into Class I or Class II, a pre-amendments device that has been classified into Class III but for
which a regulation under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring the submission of an
application for premarket approval (PMA) has not yet been issued, or a pre-amendments device that has not yet
been classified.
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III. Obtaining Information About a Device
A.

General Information

You can obtain information about device classification and regulatory requirements applicable
to a type of device in several ways. FDA's device regulations may be found at 21 CFR parts
800 - 898; the regulations classifying device types are located at 21 CFR parts 862-892. The
CDRH classification resources 3 on the CDRH web site can help you quickly ascertain how
your device type may be classified. You can also obtain information about the regulatory
requirements that may apply to a particular type of device on FDA’s web site (see resources
below).
•

Product Classification Database
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm)

•

510(k) Database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)

•

Premarket Approval Database
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm)

•

Class I and Class II Devices Exempt from 510(k) Requirements
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm)

•

Device Guidance Documents (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/guidance-documents-medical-devices-andradiation-emitting-products)

•

Division of Industry and Consumer Education (DICE), 800-638-2041 or 301-796-7100,
or by email at [email protected]

•

Office of Combination Products
(https://www.fda.gov/CombinationProducts/default.htm), 301-796-8930, or by email at
[email protected]

•

Information regarding particular types of devices regulated by CBER:
https://www.fda.gov/vaccines-blood-biologics/blood-blood-products/approved-bloodproducts.

If the resources listed above do not address your question, you may contact the associated
Division management for more information. Contact information for the CDRH Office of
Product Evaluation and Quality (OPEQ) is available at the CDRH Management Directory By
Organization. 4 Contact information for CBER is available at Contacts in the Center for
Biologics Evaluation. 5
3

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
https://www.fda.gov/about-fda/cdrh-offices/cdrh-management-directory-organization
5
https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/contacts-center-biologicsevaluation-research-cber
4

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B.

Section 513(g) Request for Information

Section 513(g) of the FD&C Act (21 U.S.C. 360c(g)) provides a means for obtaining the
agency's views about the classification and the regulatory requirements that may be
applicable to your particular device. This provision states:
Within sixty days of the receipt of a written request of any person for information respecting
the class in which a device has been classified or the requirements applicable to a device
under this Act, the Secretary shall provide such person a written statement of the
classification (if any) of such device and the requirements of this Act applicable to the device.
Section 513(g) governs requests "for information respecting the class in which a device has
been classified or the requirements applicable to a device under [the] Act." Submissions that
do not request such information are outside the scope of section 513(g).
If, based solely on the information provided with a 513(g) Request for Information, the
product at issue does not appear to be a "device" within the meaning of section 201(h) of the
FD&C Act (21 U.S.C. 321(h)), FDA will so inform the requester in our response. If, based
solely on the information provided with the request, the product does appear to be a "device"
within section 201(h) of the FD&C Act, FDA will generally provide the following
information regarding device classification and applicable FDA regulatory requirements:
•

the agency's assessment, based on the information submitted in the request, as to the
generic type of device (e.g., classification regulation) that the requester's device appears
to be within (if any);

•

the class of devices within that generic type (and if there is more than one class within
that generic type, the particular class within which the requestor's device appears to fall);

•

whether a PMA, 510(k), or neither is required in order to market devices of the
particular class within that generic type;

•

other requirements applicable to devices of the particular class within that generic type;

•

whether a guidance document has been issued regarding the exercise of enforcement
discretion over the particular class of devices within that generic type;

•

whether additional FDA requirements may apply, such as those applicable to radiationemitting products.

FDA does not review data related to substantial equivalence or safety and effectiveness in a
513(g) Request for Information. FDA's responses to 513(g) Requests for Information are not
device classification decisions and do not constitute FDA clearance or approval for marketing.
Classification decisions and clearance or approval for marketing require
submissions under different sections of the FD&C Act. The most common method of
seeking a classification decision is to submit a premarket notification in accordance with
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section 510(k) of the FD&C Act (see 21 CFR part 807, subpart E - Premarket Notification
Procedures).
FDA’s response to a 513(g) Request for Information will not address the specific types of
nonclinical, animal, or clinical testing appropriate to support clearance or approval of a
marketing application (when required). You may send a Q-submission to the Document
Control Center for review by the appropriate Review Division to receive more specific
information about your specific testing recommendations (for CDRH, see IDE Approval
Process 6; for CBER, use contact information supplied on the 513(g) Request for Information
response letter.
A 513(g) response does not constitute final Agency action, but provides responsive information
based on the information provided by the requestor.

C.

Formal Jurisdictional Determinations within FDA

If it is unclear to you which Center has jurisdiction over your product, including any
combination product for which the lead Center has not yet been determined, it may be
appropriate to contact the Office of Combination Products (OCP) to discuss your product's
jurisdiction and whether to submit a formal Request for Designation (RFD) under section 563
of the FD&C Act (21 U.S.C. 360bbb-2) rather than submitting a 513(g) Request for
Information. 7 The RFD process is used to obtain a formal agency determination concerning
the classification of a product as a drug, device, biological product, or combination product 8
subject to section 503(g) of the FD&C Act (21 U.S.C. 353(g)), and/or respecting which
agency component(s) will regulate the product. 9

IV. Submitting a 513(g) Request for Information
A 513(g) Request for Information submission should be identified as a 513(g) Request for
Information. One electronic copy (eCopy) 10 or one complete paper copy of the request should
be sent to the current address found on the following websites:
•

6

https://www.fda.gov/medical-devices/how-study-and-market-your-device/ecopyprogram-medical-device-submissions, for devices regulated by CDRH; and

https://www.fda.gov/medical-devices/device-advice-investigational-device-exemption-ide/ide-approval-process
Additional information on how combination products are assigned a lead Center for their premarket review and
their regulation is available on OCP’s webpage (https://www.fda.gov/combination-products).
8
Combination product is defined at 21 CFR 3.2(e).
9
For additional information on RFDs, refer to FDA guidances entitled “How to Write a Request for Designation
(RFD)” (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-write-requestdesignation-rfd ) and “How to Prepare a Pre-Request for Designation (Pre-RFD)”
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-prepare-pre-requestdesignation-pre-rfd)
10
Please refer to the FDA guidance, eCopy Program for Medical Device Submissions
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-devicesubmissions), for additional information on eCopy program.
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•

https://www.fda.gov/about-fda/about-center-biologics-evaluation-and-researchcber/regulatory-submissions-electronic-and-paper, for devices regulated by CBER.

Please note that if submitting an eCopy, it must be accompanied by a single paper copy of your
signed cover letter.
User Fees
The Act, as amended by the FDA Amendments Act of 2007 (FDAAA) (Public Law 110-85),
requires FDA to collect user fees for 513(g) Requests for Information. See section
738(a)(2)(A)(ix) of the FD&C Act (21 U.S.C. 379j(a)(2)(A)(ix)). FDA may not accept your
513(g) for review until you have paid all fees owed, including all required establishment
registration fees. See section 738(f)(1) of the FD&C Act (21 U.S.C. 379j(f)(1)). When FDA
has received all fees owed, our review of your 513(g) Request for Information will begin as of
that date.
As explained above, if the submission does not request information respecting the class in
which a device has been classified and/or the requirements applicable to a device under the
Act, it is not a Request for Information governed by section 513(g) of the Act. Such requests
do not require a response from FDA. FDA intends to refund any user fee submitted with a
request that is not governed by section 513(g) of the FD&C Act.
For additional information on user fees for 513(g) requests for information see the guidance
document “User Fees for 513(g) Requests for Information.” 11

V.

Contents of a 513(g) Request for Information

The 513(g) Request for Information should contain the following:
•

a cover letter,

•

a description of the device, 12

•

a description of what the device is to be used for, and

•

any proposed labeling or promotional material for the device and, as applicable, any
labeling or promotional material of a similar, legally marketed device, if available.

Cover Letter
Your cover letter should identify your request as a “513(g) Request for Information.” Your
cover letter should include:
•
11

the date of the request,

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-513g-requestsinformation
12
A 513(g) Request for Information should seek classification information and/or regulatory requirements for a
single product and may include multiple uses of the product. Requests for classification information and regulatory
requirements for multiple products should be divided up so that a separate Request for Information and user fee are
submitted for each product.
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•

the name of the device,

•

your specific question(s) concerning the class in which a device has been classified
and/or the regulatory requirements applicable to a device,

•

the requestor’s name, address, telephone number, fax number, and email address, 13 14
and

•

the 513(g) requestor’s signature.

Description of the Device
As applicable, the description of the device should include:
•

a list of materials and components used in/with the device,

•

photographs, engineering drawings, and/or samples of the device,

•

a summary of the device’s operational principles,

•

a description of the type and amount of energy to be used or delivered by the device,
and

•

a description of similar devices in commercial distribution in the United States, if
available.

15

Device Uses
You should include the following information:
•

the disease or condition with respect to which the device is to be used

•

prescription versus over-the-counter use,

•

part of the body or type of tissue applied to or interacted with,

•

frequency of use,

•

physiological purpose (e.g., removes water from blood, transports blood, etc.),

•

patient population; and

13

You should provide the contact information for a single point of contact. The contact information should be
associated with the person submitting the Request for Information as the term person is defined in section
201(e) of the FD&C Act.
14
For additional information about email communications with CBER, please see SOPP 8119: Use of Email for
Regulatory Communications, available at https://www.fda.gov/media/108992/download.
15
Any sample device can be returned at the request of the submitter.
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•

any other labeling information related to the patient use of the device.

Labeling
You should provide any proposed labeling, including proposed promotional material for the
device or any labeling or promotional material of a similar, legally marketed device. If no
proposed labeling is available for the described device or for a similar legally marketed
device, this should be noted in the cover letter.
Additions to a 513(g) Request for Information
Once FDA has received your 513(g) Request for Information and user fee, you may not
modify that 513(g) request by subsequently adding a new question, use, or technology. We
would consider the addition of a new question, use, or technology to a pending Request for
Information to be a new 513(g) request subject to an additional user fee, to which we intend to
respond separately.

VI. Responding to a 513(g) Request for Information in
CDRH or CBER
Our response to a 513(g) Request for Information will be responsive to the questions posed in
the request. We intend to issue our response within 60 days of receipt. Our response will
generally fall into one of the following categories indicating that, based solely on the
information provided in the 513(g) Request for Information, it appears that the product you
have identified is:
•

•

•

a device within the meaning of section 201(h) of the FD&C Act, and
o appears to be an unclassified pre-amendments device type and therefore is
subject to the 510(k) requirement;
o appears to be a post-amendments device type that has not yet been
reclassified and therefore is subject to the PMA requirement; or
o appears to be a device that is a classified device type. We will generally
identify the generic type of device (e.g., classification regulation) that
your device appears to be within, the class of device within which your
device appears to fall, and the type of submission, if any, required in order
to market devices of the particular class within that generic type:
 Class I or II subject to the 510(k) requirement;
 Class I or II exempt from the 510(k) requirement;
 Class III subject to the 510(k) or PMA requirements; OR
not a device,
o but may be another type of product regulated by FDA. In this case, we would
provide you with contact information for another component within FDA; or
o and appears not to be a product for which FDA has jurisdiction; OR
a combination product where it is not clear which Center has primary jurisdiction. If
you would like to discuss further the assignment of this product, we recommend you
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contact the Office of Combination Products.
If your 513(g) Request for Information is incomplete and we are unable to provide information
regarding classification and/or applicable requirements because you have not submitted
sufficient information to us, we intend to contact the submitter and request additional
information. If FDA does not receive a response within 30 days of our request, we may
consider a 513(g) to be withdrawn. In this instance, FDA may issue a notice of withdrawal.

VII. 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 average 12 hours per
response, including the time to review instructions, search existing data sources, gather the
data needed, and complete and review the information collection. Send comments regarding
this burden estimate or suggestions for reducing this burden to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[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 0910-0705 (expires 06-30-2021).
This guidance also refers to currently approved collections of information found in FDA
regulations. The collections of information in 21 CFR 807 subpart E have been approved
under OMB control number 0910-0120; the collections of information in 21 CFR part 814
have been approved under OMB control number 0910-0231; the collections of information in
21 CFR part 801 have been approved under OMB control number 0910-0485; and the
collections of information in 21 CFR 860.123 have been approved under OMB control number
0910-0138.

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