Section 3308 of The Food and Drug Omnibus Reform Act of 2022 (FDORA) enacted as part of 
the Consolidated Appropriations Act, 2023 (December 29, 2022) amended section 517A(a)(1) of 
the Federal Food, Drug, and Cosmetic Act. This guidance was developed and issued prior to the 
enactment of FDORA, and certain sections of this guidance may no longer be current as a 
result. FDA is assessing how to revise this guidance to represent our current thinking on this 
topic. For more information please contact the CDRH Ombudsman at 
CDRHOmbudsman@fda.hhs.gov 
  Contains Nonbinding Recommendations 
 
Center for Devices and Radiological 
Health (CDRH) Appeals Processes: 
Questions and Answers About 517A 
 
Guidance for Industry and 
Food and Drug Administration Staff 
 
Document issued on March 27, 2020.  
Document originally issued on July 30, 2014 
As of March 27, 2020, this document supersedes Center for Devices and 
Radiological Health Appeals Processes: Questions and Answers about 517A  
Guidance for Industry and Food and Drug Administration Staff issued on 
August 1, 2019. 
For questions about this document, contact the CDRH Ombudsman at 301-796-5699 or 
CDRHOmbudsman@fda.hhs.gov. 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health   
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-2013-D-0501. 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 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the 
document number 19003 and complete title of the guidance in the request.   
Contains Nonbinding Recommendations 
 
 
Table of Contents 
 
 
I.  Introduction ........................................................................................................................................................... 1 
II.  Background ........................................................................................................................................................... 1 
III.  Questions about Section 517A .......................................................................................................................... 3 
A.  What is a Significant Decision? .................................................................................................................... 3 
B.  What is a substantive summary? ................................................................................................................... 4 
C.  Who may request documentation of 517A decisions under section 517A of the FD&C Act, and how does 
this provision relate to requests under the Freedom of Information Act (FOIA)?...................................................... 5 
D.  How to request a substantive summary under section 517A of the FD&C Act? ...................................5 
 
  Contains Nonbinding Recommendations 
Center for Devices and Radiological 
Health (CDRH) Appeals Processes: 
Questions and Answers About 517A 
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
This guidance document provides the Center for Devices and Radiological Health (CDRH or 
the Center) interpretation of key provisions set forth in section 517A of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act),1  as those provisions pertain to requests for appeals of 
significant decisions under 21 CFR 10.75, as well as for the timeframes and procedures of 
regulatory decisions and actions taken by CDRH under 21 CFR 800.75. 
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. Background
Section 517A of the FD&C Act contains provisions for the documentation and review of 
certain decisions in the premarket review of device submissions. Specifically, this provision 
states: 
1 Section 517A of the FD&C Act was added by section 603 of the FDA Safety and Innovation Act (FDASIA) of 
2012, and subsequently amended by sections 3051 and 3058 of the 21st Century Cures Act of 2016.
1  Contains Nonbinding Recommendations 
(a) DOCUMENTATION OF RATIONALE FOR SIGNIFICANT DECISIONS. (1)
IN GENERAL.The Secretary shall provide a substantive summary of the scientific
and regulatory rationale for any significant decision of the Center for Devices and
Radiological Health regarding submission or review of a report under section 510(k),
an application under section 515, a request for designation under section 515B2, or an
application for an exemption under section 520(g), including documentation of
significant controversies or differences of opinion and the resolution of such
controversies or differences of opinion.
(2) PROVISION OF DOCUMENTATION.Upon request, the Secretary shall
furnish such substantive summary to the person who is seeking to submit, or who has
submitted, such report or application.
(3) APPLICATION OF LEAST BURDENSOME REQUIREMENTS.  The
substantive summary required under this subsection shall include a brief statement
regarding how the least burdensome requirements were considered and applied
consistent with section 513(i)(1)(D), section 513(a)(3)(D), and section 515(c)(5), as
applicable.
(b) REVIEW OF SIGNIFICANT DECISIONS.
(1) REQUEST FOR SUPERVISORY REVIEW OF SIGNIFICANT DECISION.
Any person may request a supervisory review of the significant decision described in
subsection (a)(1). Such review may be conducted at the next supervisory level or
higher above the individual who made the significant decision.
(2) SUBMISSION OF REQUEST.A person requesting a supervisory review under
paragraph (1) shall submit such request to the Secretary not later than 30 days after
such decision and shall indicate in the request whether such person seeks an in-person
meeting or a teleconference review.
(3) TIMEFRAME.
(A) IN GENERAL.Except as provided in subparagraph (B), the Secretary shall
schedule an in-person or teleconference review, if so requested, not later than 30 days
after such request is made. The Secretary shall issue a decision to the person
requesting a review under this subsection not later than 45 days after the request is
made under paragraph (1), or, in the case of a person who requests an in-person
meeting or teleconference, 30 days after such meeting or teleconference.
(B) EXCEPTION.Subparagraph (A) shall not apply in cases that are referred to
experts outside of the Food and Drug Administration.
21 CFR 10.75 was amended to add paragraph (e) to require that requests for internal agency 
supervisory review of a decision within CDRH also comply with  800.75 (21 CFR 800.75).  
This change to the regulations encompasses both significant decisions under section 517A of 
the FD&C Act and other decisions by CDRH employees for which review is requested 
through the supervisory chain within CDRH. Further, 21 CFR 800.75 includes timeframes 
for industry for decisions made by CDRH that are outside the scope of section 517A of the 
FD&C Act.  
CDRH has developed this guidance document as a companion to Center for Devices and 
2 Section 3051 of the Cures Act, Breakthrough Devices added section 515B of the FD&C Act, as amended by section 
901(f)(2) of the FDA Reauthorization Act of 2017 (Public Law 115-52). 
2   
Contains Nonbinding Recommendations 
Radiological Health Appeals Processes  Guidance for Industry, Stakeholders, and Food and 
Drug Administration Staff 3 to provide further clarity of several provisions of the law and 
regulations. 
 
 
III.  Questions about Section 517A 
A.  What is a Significant Decision? 
 
The documentation and review procedures required by section 517A of the FD&C Act apply 
only to significant decisions concerning submissions under sections 510(k) (Premarket 
Notification), 515 (Premarket Approval or PMA/Humanitarian Device Exemption or 
HDE), 515B (Breakthrough Devices), or 520(g) (Investigational Device Exemption or 
IDE) of the FD&C Act. Significant decision is not explicitly defined in section 517A of 
the FD&C Act. For purposes of this guidance, we refer to significant decisions made by 
CDRH that are within the scope of section 517A as 517A decisions. Therefore, a request 
for supervisory review of a 517A decision must follow the procedures and timeframes set 
forth in section 517A(b) of the FD&C Act and its implementing regulations found in 21 
CFR 800.75.  As stated in 21 CFR 800.75, 517A decisions include the following types of 
decisions: 
 
  510(k) (Premarket Notification): Not Substantially Equivalent; Substantially Equivalent; 
  PMA/HDE (Premarket Approval/Humanitarian Device Exemption): Not Approvable; 
Approvable; Approval; Denial; 
  Breakthrough Device Designation Request4: Request for breakthrough designation for 
devices subject to 510(k), PMA, or De Novo classification. Grant; Denial of request for 
breakthrough designation; 
  IDE (Investigational Device Exemption): Disapproval; Approval; 
  Failure to Reach Agreement on a Protocol under Section 520(g)(7) of the FD&C Act; 
and 
  Clinical Hold Determinations under Section 520(g)(8) of the FD&C Act. 
 
Under 21 CFR 800.75, the timeframes and procedures specified in section 517A of the 
FD&C Act for 517A decisions regarding premarket submissions apply to sequential requests 
for supervisory review of such decisions within CDRH. For example, if a company that 
requests supervisory review of a 517A decision at the Office level further appeals the Office 
decision to the next higher level, FDA would apply the procedures and timeframes specified 
in section 517A of the FD&C Act to both of these appeals. 
 
There are regulatory actions that do not constitute 517A decisions for purposes of 21 CFR 
                                                      
3 Center for Devices and Radiological Health Appeals Processes  Guidance for Industry and Food and Drug 
Administration Staff, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-
devices-and-radiological-health-cdrh-appeals-processes.  
4 Breakthrough Devices Program  Guidance for Industry and Food and Drug Administration Staff, available at: 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program.   
  3   
Contains Nonbinding Recommendations 
800.75 and thus are not subject to 21 CFR 800.75(b)(1).  These types of appeals are 
subject to 21 CFR 10.75 and 21 CFR 800.75(b)(2). CDRH refers to these decisions as 
non-517A decisions.  Examples of non-517A decisions include, but are not limited to, 
the following: 
 
  510(k) Requests for Additional Information; 
  De Novo Requests for Additional Information and Final Decisions; 
  PMA Major Deficiency Letters; 
  510(k), PMA and HDE Refuse to Accept/Refuse to File Letters; 
  Postmarket Surveillance Orders under Section 522 of the FD&C Act; 
  Clinical Laboratory Improvement Amendments (CLIA) Waiver Decisions; 
  Warning Letters; and 
  Response Letter to a Request for Information under Section 513(g) of the FD&C Act. 
 
These requests for supervisory review would not trigger the requirements under section 517A 
of the FD&C Act. 
 
Note that the requirements for non-517A decisions within 21 CFR 10.75 and 21 CFR 
800.75(b)(2) also apply to sequential requests for supervisory review of such decisions within 
CDRH. As such, a request for supervisory review within CDRH under 21 CFR 10.75 for a 
non-517A decision that is not received by CDRH within 60 days after the date of the decision 
involved will be denied as untimely, unless CDRH, for good cause related to circumstances 
beyond the control of the submitter, such as snow emergency, Federal Government shutdown, 
or other unforeseen emergency event,  permits the request to be filed after 60 days5. 
 
B.  What is a substantive summary? 
 
Section 517A of the FD&C Act requires the Center to provide, upon request of a person who 
is seeking to submit or who has submitted a 510(k), PMA, IDE, HDE, or Breakthrough 
Designation Request, a substantive summary of the scientific and regulatory rationale for 
any 517A decision regarding such submission, including documentation of how the least 
burdensome requirements were considered and applied, and documentation of significant 
controversies or differences of opinion and the resolution thereof. For example, when the 
submitter of a Premarket Notification under section 510(k) of the FD&C Act receives a 
Substantially Equivalent or Not Substantially Equivalent decision from CDRH, the submitter 
may then request, and CDRH must provide, a substantive summary of the rationale for the 
decision. 
 
For decisions that are subject to this provision, the substantive summary may be the final 
version of the review memorandum by the lead reviewer or another summary document that 
includes the following elements: 
 
  An explanation of the rationale for the regulatory decision; 
                                                      
5  21 CFR 800.75(b)(2) 
  4   
Contains Nonbinding Recommendations 
  An explanation regarding how the least burdensome requirements were considered 
and applied consistent with sections 513(i)(1)(D), 513(a)(3)(D), and 515(c)(5) of the 
FD&C Act. 
  Documentation of significant controversies or differences of opinion, i.e., ones the 
resolution of which had a direct bearing on the regulatory decision; and 
  References to published literature and consensus standards upon which the decision- 
maker relied. 
C.  Who may request documentation of 517A decisions 
under section 517A of the FD&C Act, and how does this 
provision relate to requests under the Freedom of 
Information Act (FOIA)? 
 
FDA interprets section 517A(a)(2) of the FD&C Act to permit persons who have submitted or 
who are seeking to submit 510(k)s, PMAs, IDEs, HDEs, or a Breakthrough Designation Request 
to request substantive summaries of 517A decisions regarding their own device (not the devices 
of others) without having to file a request under FOIA. For example, a sponsor, who has received 
a decision for an IDE, may request a substantive summary of a decision. 
 
Since FDA will only be providing these summaries to the owner of any proprietary information 
contained therein, generally there should not be any need to withhold trade secret or confidential 
commercial information (CCI) or any other information in the summary. If someone other than the 
owner of a device wishes to obtain a substantive summary of a 517A decision regarding such 
device, that person would need to file a FOIA request. Trade secret and CCI would be withheld in 
FDAs response to such a FOIA request, but there would be no information exempt from 
disclosure under 5 U.S.C.  552(b)(5). 
 
D.  How to request a substantive summary under section 
517A of the FD&C Act? 
 
A request for substantive summary under 517A(a)(2) of the FD&C Act should be made by 
submitting the request via the processes established for premarket submissions to CDRHs 
Document Control Center.6  The request should clearly be identified as a request for substantive 
summary under 517A, including by prominently stating Request for Substantive Summary under 
517A at the top of the request, and should clearly identify the associated identifying number for 
the relevant premarket submission (e.g., 510(k) submission number).  
                                                      
6 See the guidance eCopy Program for Medical Device Submissions  (https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/ecopy-program-medical-device-submissions). 
  5