REGULATORY UPDATE: FDA Issues Revised Draft Guidance on Remote Regulatory Assessments

The Food and Drug Administration issued a revised draft guidance for industry on Friday, “Conducting Remote Regulatory Assessments – Questions and Answers,” that describes the agency’s current thinking regarding the use of remote regulatory assessments (RRAs).

Through the guidance, FDA seeks to increase industry’s understanding of RRAs, which the agency uses to conduct oversight, mitigate risk, meet public health needs and help maximize compliance of FDA-regulated products.

FDA first issued the draft guidance in July 2022 but revised and reissued the draft guidance in response to public comments and recent amendments to the Federal Food, Drug, and Cosmetic Act. The revisions address the following topics:

• The benefits of an RRA and any consequences for not participating.
• How a facility will know an RRA is being requested and whether it is mandatory or voluntary.
• When and how FDA may initiate an RRA.
• How FDA may conduct RRAs in relation to FDA inspections or to activities by state and foreign regulatory partners.
• What an establishment should expect during an RRA, including overall process, technological expectations and how consent may be established for a voluntary RRA.
• How FDA will seek to provide for ongoing communication between FDA and an establishment.
• What may occur upon the completion of an RRA.

FDA is accepting feedback on the draft guidance through March 26. Submission instructions are available in the Federal Register notice.