Contains Nonbinding Recommendations 
Nonbinding Feedback After Certain 
FDA Inspections of Device 
Establishments
 
______________________________________________________________________________ 
Guidance for Industry and 
Food and Drug Administration Staff 
Document issued on April 22, 2020. 
The draft of this document was issued on February 19, 2019. 
For questions about this document regarding CDRH-regulated devices, contact the Office of 
Regulatory Programs (ORP)/DRP2: Division of Establishment Support at 301-796-5476. For 
questions about this document regarding CBER-regulated devices, contact the Office of 
Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010. For 
questions about ORA implementation, contact ORAPolicyStaffs@fda.hhs.gov. 
The OMB control number for this information collection is 0910-0886 (expires 04-30-2023). 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Center for Biologics Evaluation and Research 
Office of Regulatory Affairs 
1  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-2018-D-4711. 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 17047 and complete title of the guidance in the request. 
CBER 
Additional copies are available from the Center for Biologics Evaluation and Research (CBER), 
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., 
Bldg. 71, Room 3128, Silver Spring, MD 20993-0002, 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. 
ORA
 
Additional copies are available from the Internet. You may also send an e-mail request to 
ORAPolicyStaffs@fda.hhs.gov. 
2 Contains Nonbinding Recommendations 
Table of Contents 
I.  Introduction .......................................................................................................................................................... 4 
II.  Background ........................................................................................................................................................... 5 
III.  Submitting a Timely Request for Nonbinding Feedback ...................................................................................... 5 
IV.  Statutory Eligibility Criteria for Nonbinding Feedback ....................................................................................... 6 
V.  Justification of Request ......................................................................................................................................... 7 
VI.  Proposed Responsive Actions ............................................................................................................................... 7 
VII.  Nonbinding Feedback ........................................................................................................................................... 7 
VIII. Paperwork Reduction Act of 1995 ........................................................................................................................ 8 
3 Contains Nonbinding Recommendations 
Nonbinding Feedback After Certain 
FDA Inspections of Device 
Establishments 
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 
FDA is issuing this guidance document to comply with section 702 of the FDA Reauthorization 
Act of 2017 (FDARA) (Public Law 115-52), which amended section 704 of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act). The purpose of this guidance is to explain how the owner, 
operator, or agent in charge of a device establishment may submit a request for nonbinding 
feedback to FDA regarding actions the firm has proposed to take to address certain kinds of 
inspectional observations that have been documented on an FDA Inspectional Observations 
Form (Form FDA 483) and issued to the firm upon completion of an inspection of the firms 
establishment. This guidance identifies a standardized method for communicating and submitting 
requests for nonbinding feedback and describes how FDA evaluates and responds to such 
requests. 
FDAs 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. 
4 Contains Nonbinding Recommendations 
II.  Background 
Section 704(h)(2) was added to the FD&C Act in 2017 to require FDA to provide nonbinding 
feedback in certain circumstances after an FDA inspection of a device establishment. Timely 
nonbinding feedback can help device firms determine whether proposed actions to address 
inspectional observations are adequate, possibly avoiding unnecessary investment in potential 
solutions not likely to satisfactorily address an inspectional observation. 
FD&C Act section 704(h)(2) states: 
(A) The Secretary shall, with respect to a request described in subparagraph (B), provide 
nonbinding feedback with respect to such request not later than 45 days after the 
Secretary receives such request. 
(B) A request described in this subparagraph is a request for feedback 
(i)  that is made by the owner, operator, or agent in charge of such establishment in a 
timely manner; and 
(ii) with respect to actions proposed to be taken by a device establishment in a 
response to a report received by such establishment pursuant to subsection (b) that 
involve a public health priority, that implicate systemic or major actions, or relate 
to emerging safety issues (as determined by the Secretary). 
III.  Submitting a Timely Request for Nonbinding Feedback 
To demonstrate that the request is being made by the owner, operator, or agent in charge1 of 
the device establishment, the request should come from the person to whom FDA issues the 
Form FDA 483 or from someone who can otherwise demonstrate to the Agency that they are the 
owner, operator, or agent in charge of the establishment or a designated representative of such 
person(s) (hereafter, requestors). 
A request for nonbinding feedback must also be made in a timely manner.2 To be considered 
timely, requests for nonbinding feedback should be submitted no later than 15 business days 
after issuance of a Form FDA 483. If a firm is also submitting a response to a Form FDA 483,3
FDA recommends that the response and request for nonbinding feedback be included in the same 
submission but as two distinct documents. 
Requests for nonbinding feedback should be submitted to the same FDA contact who is 
identified to receive the submission of a response to the Form FDA 483.4
                                                          
1 FD&C Act section 704(h)(2)(B)(i). 
2 FD&C Act section 704(h)(2)(B)(i). 
3 See https://www.gpo.gov/fdsys/pkg/FR-2009-08-11/pdf/E9-19107.pdf. 
4 FDA investigators provide written instructions about how and where to submit responses to a Form FDA 483 at the 
end of the inspection. Requestors should use the same contact information identified in those instructions. 
5 Contains Nonbinding Recommendations 
The request for nonbinding feedback should include: 
  An email subject line or cover letter with a header that clearly and conspicuously states 
Request for Nonbinding FDA Feedback After a Device Inspection; 
  The name, address, phone number, and email address of the person submitting the 
request; 
  The name, address, and FDA Establishment Identification (FEI) number of the 
establishment that was inspected and the date(s) of the inspection; and 
  A justification describing how the request meets at least one of the eligibility criteria 
specified in FD&C Act section 704(h)(2)(B)(ii), as described in Section IV below. 
IV.  Statutory Eligibility Criteria for Nonbinding Feedback 
A request for nonbinding feedback under section 704(h)(2) must describe how one or more 
observations involve a public health priority, implicate systemic or major actions, or relate 
to emerging safety issues (as determined by [FDA]).5
The following describe situations where FDA believes the request for nonbinding feedback 
meets these statutory criteria: 
  The FDA-documented observation(s) in the Form FDA 483 involve a public health 
priority and require resolution because such conditions have resulted in, or if unaddressed 
are likely to result in, the release of a violative product that may cause death or serious 
injury. 
  The FDA-documented observation(s) in the Form FDA 483 indicate that systemic or 
major deficiencies with the quality system or subsystem(s), when considering all 
pertinent factors, have resulted in, or if unaddressed are likely to result in, the release of 
nonconforming, violative, and/or defective finished devices that may pose a serious risk 
to public health. 
  The FDA-documented observation(s) in the Form FDA 483 relate to an emerging safety 
issue that, if unaddressed, is likely to result in the release of devices that are likely to 
cause death or serious injury. 
                                                          
5 FD&C Act section 704(h)(2)(B)(ii). 
6 Contains Nonbinding Recommendations 
V.  Justification of Request 
The request for nonbinding feedback should contain a justification why the requestor believes at 
least one of the eligibility criteria described in Section IV is met. This justification may relate to 
an individual inspectional observation for which the nonbinding feedback is being requested, 
more than one observation, or all of the observations. Requestors should explain in detail how 
each individual observation for which nonbinding feedback is requested meets one or more of 
the eligibility criteria within the justification. Under the statute, FDA is required to provide 
nonbinding feedback on those observations in the request for nonbinding feedback that meet at 
least one of the statutory eligibility criteria. If none of the eligibility criteria are met, the statute 
does not require FDA to provide nonbinding feedback regarding proposed actions related to the 
observation. 
VI.  Proposed Responsive Actions 
The request for nonbinding feedback should clearly state the inspectional observation(s) for 
which nonbinding feedback is being requested, followed by the proposed actions in response to 
the observation(s). The proposed actions should include a detailed description and timeline of the 
activities the firm plans to take to completely and adequately correct the conditions described in 
the observations and prevent recurrence. For FDA to properly evaluate the adequacy of any 
proposed actions to address the observations, the submission should also include supporting 
documentation, as appropriate.  
VII. Nonbinding Feedback 
Upon receiving a timely request for nonbinding feedback and verifying that the request has been 
made by the owner, operator, or agent in charge of the device establishment or a designated 
representative of such person(s), FDA determines whether one or more of the statutory eligibility 
criteria (see Section IV) have been met. To do so, FDA considers the justification provided in the 
request. If none of the eligibility criteria are met, FDA notifies the requestor within 45 calendar 
days that the request is not eligible to receive nonbinding feedback.6 Otherwise, the statute 
requires FDA to provide nonbinding feedback about the proposed actions for addressing 
inspectional observations within 45 calendar days of the Agencys receipt of the request. 
FDAs nonbinding feedback should identify whether the proposed actions to address inspectional 
observations, if appropriately implemented, appear adequate, partially adequate, or inadequate. If 
FDA determines the proposed actions appear partially adequate or inadequate, FDA intends to: 
                                                          
6 While the statute does not require FDA to provide nonbinding feedback for untimely requests or requests for 
nonbinding feedback that do not meet the statutory eligibility criteria under section 704(h)(2) of the FD&C Act, 
FDA may choose to respond to these requests through an alternate mechanism (e.g., written correspondence, 
teleconference, face-to-face meeting) at its discretion. 
7 Contains Nonbinding Recommendations 
1.  Acknowledge the proposed actions submitted, including references (where appropriate) 
to sections, page numbers, or tables; 
2.  Explain why the proposed actions (or elements of the proposed actions) do not appear 
adequate; and 
3.  Provide a recommendation of what may be needed for FDA to consider the proposed 
actions (or elements of the proposed actions) adequate. 
If FDA determines that the proposed actions (or elements of the proposed actions) appear 
adequate based on the information provided, FDA intends to notify the requestor. FDAs 
nonbinding feedback represents the Agencys best recommendation for the establishments 
specific factual circumstances based on the information provided in the request for nonbinding 
feedback and other information known at that point in time. FDAs nonbinding feedback is 
intended to be used to inform the firms implementation of actions in response to inspectional 
observations. Firms are not required to adhere to the nonbinding feedback provided by FDA; a 
firm may use an alternative approach to correct inspectional observations. 
FDAs nonbinding feedback, if implemented, may not adequately address the cause of the 
problems that led to the inspectional observations, and additional action may be warranted. 
Implementation of FDAs nonbinding feedback does not prevent FDA from citing the same or 
other inspectional observations or otherwise taking regulatory action. FDAs nonbinding 
feedback does not preclude or limit FDAs regulatory options. It is the responsibility of the 
owners, operators, and agents in charge of the device establishment to ensure compliance with 
applicable laws and regulations administered by FDA. 
VIII.  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-
3521). 
The time required to complete this information collection is estimated to average 500 hours per 
response. Send comments regarding this burden estimate or suggestions for reducing this burden to: 
FDA PRA Staff, 
Office of Operations, 
Food and Drug Administration, 
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 0910-0886 (expires 04-30-2023). 
8