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 6-30-2024). 
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 1-800-
835-4709 or 240-402-8010, or by email at ocod@fda.hhs.gov.
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 CDRH-
Guidance@fda.hhs.gov 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, ocod@fda.hhs.gov, or from the Internet at
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-
biologics/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 Agencys 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). 
10  Contains Nonbinding Recommendations 
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 pre- 
amendments 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 pre-
amendments 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. 
11  Contains Nonbinding Recommendations 
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 resources3 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 FDAs 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-advice-
comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-
radiation-emitting-products)
 Division of Industry and Consumer Education (DICE), 800-638-2041 or 301-796-7100,
or by email at DICE@cdrh.fda.gov
 Office of Combination Products
(https://www.fda.gov/CombinationProducts/default.htm), 301-796-8930, or by email at
combination@fda.gov 
 Information regarding particular types of devices regulated by CBER:
https://www.fda.gov/vaccines-blood-biologics/blood-blood-products/approved-blood-
products.
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  
4 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-biologics-
evaluation-research-cber 
12  Contains Nonbinding Recommendations 
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 radiation-
emitting 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 
13  Contains Nonbinding Recommendations 
section 510(k) of the FD&C Act (see 21 CFR part 807, subpart E - Premarket Notification 
Procedures). 
FDAs 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 
Process6; 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 product8 
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: 
 https://www.fda.gov/medical-devices/how-study-and-market-your-device/ecopy-
program-medical-device-submissions, for devices regulated by CDRH; and
6 https://www.fda.gov/medical-devices/device-advice-investigational-device-exemption-ide/ide-approval-process 
7 Additional information on how combination products are assigned a lead Center for their premarket review and 
their regulation is available on OCPs 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-request-
designation-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-request-
designation-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-device-
submissions), for additional information on eCopy program.  
14  Contains Nonbinding Recommendations 
 https://www.fda.gov/about-fda/about-center-biologics-evaluation-and-research-
cber/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: 
 the date of the request,
11 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-513g-requests-
information  
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. 
15  Contains Nonbinding Recommendations 
 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 requestors name, address, telephone number, fax number, and email address,13 14
and
 the 513(g) requestors 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, 15
 a summary of the devices 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.
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. 
16  Contains Nonbinding Recommendations 
 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
appears to be an unclassified pre-amendments device type and therefore is
o
subject to the 510(k) requirement;
appears to be a post-amendments device type that has not yet been
o
reclassified and therefore is subject to the PMA requirement; or
appears to be a device that is a classified device type. We will generally
o
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,
but may be another type of product regulated by FDA. In this case, we would
o
provide you with contact information for another component within FDA; or
and appears not to be a product for which FDA has jurisdiction; OR
o
 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
17  Contains Nonbinding Recommendations 
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  
PRAStaff@fda.hhs.gov  
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 06-30-2024). 
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. 
18