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GUIDANCE DOCUMENT

Conducting Remote Regulatory Assessments Questions and Answers Guidance for Industry June 2025

Final
Docket Number:
FDA-2022-D-0810
Issued by:
Guidance Issuing Office
Office of Inspections and Investigations
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Drug Evaluation and Research
Center for Tobacco Products
Center for Veterinary Medicine
Human Foods Program
Office of the Commissioner, Office of the Chief Medical Officer, Office of Combination Products

FDA is announcing the availability of a final guidance for industry entitled “Conducting Remote Regulatory Assessments--Questions and Answers.”  The final guidance makes further revisions to and replaces the revised draft guidance entitled “Conducting Remote Regulatory Assessments--Questions and Answers; Draft Guidance for Industry,” which was announced in the Federal Register on January 26, 2024 (89 FR 5244).  FDA issued the revised draft guidance to describe the Agency’s thinking regarding its use of Remote Regulatory Assessments (RRAs), to help increase the industry’s understanding of voluntary and mandatory RRAs, and to facilitate FDA’s process for conducting remote assessments for FDA-regulated products outside of the COVID-19 public health emergency.  The revised draft guidance  reflected consideration of comments on a preceding draft guidance of the same title as well as revisions to align with 2022 changes in law (the Food and Drug Omnibus Reform Act of 2022 (FDORA)), including to address a requirement to issue guidance related to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act  (i.e., requests for records in advance of or in lieu of an inspection; such requests are a type of RRA).  The final guidance additionally reflects consideration of comments from interested parties on the revised draft guidance.  

The final guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115).  The final guidance represents the current thinking of FDA on “Conducting Remote Regulatory Assessments.”  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. 

 


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0810.

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