FDA Issues Final Guidance for Industry on its Use of Remote Regulatory Assessments
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The U.S. Food and Drug Administration (FDA) recently published a final guidance for industry, titled, Conducting Remote Regulatory Assessments—Questions and Answers. The final guidance revises and replaces an FDA draft guidance of the same title that was published in January 2024.
A remote regulatory assessment (RRA) is an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements. When faced with travel restrictions during the COVID-19 pandemic, FDA relied on RRAs to conduct oversight, mitigate risk, meet public health needs, and evaluate compliance of FDA-regulated products. Since that time, FDA has noted the value of RRAs and concluded that they are a beneficial oversight tool outside the COVID-19 pandemic.
The guidance describes FDA's current thinking regarding the agency’s use of RRAs and provides answers to frequently asked questions. It is intended to help increase 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 The final guidance reflects consideration of comments made on the preceding draft guidance of the same name, as well as changes in law made since the earliest version of the draft guidance published in 2022.
Specifically, the final guidance includes changes that:
- Distinguish more clearly between mandatory and voluntary RRA requests
- Clarify how FDA intends to inform establishments of the terms of participation in voluntary RRAs and obtain their consent to conduct the RRA
- Facilitate transparency and consistency in FDA's use of RRAs across regulated products, as applicable
- Clarify mechanisms for electronic records reviews and conditions under which live data access might occur
- Address concerns about confidentiality and security of establishment information reviewed by FDA.
The final guidance also addresses the 2022 requirement for issuance of final guidance relating to the agency's use of section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act, which relates to requests for records in advance of or in lieu of an inspection, as such requests are a type of RRA.
Comments may be submitted on the final guidance at any time at regulations.gov under Docket No. FDA-2022-D-0810.
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