Final FDA Guidance on Remote Regulatory Assessments

The U.S. FDA published the final Guidance for Industry Conducting Remote Regulatory Assessments - Questions and Answers. The final guidance describes how the FDA will use Remote Regulatory Assessments (RRAs) for FDA-regulated products.

This final guidance follows from a revised draft guidance published in January 2024. The current guidance now considers stakeholder comments and changes in law (Food and Drug Omnibus Reform Act, 2022, including device establishments) The final guidance includes changes to:

• 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;
• 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 information reviewed by the FDA.

What is a Remote Regulatory Assessment (RRA)?

An RRA is an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements. Some of these tools include remote records requests, remote livestreaming video of operations, teleconferences, and screen sharing.
During the pandemic, the FDA already used RRAs, domestically and abroad, for certain FDA-regulated products to help the agency conduct oversight when on-site inspections could not be conducted. Due to the success of these tools, the agency will continue to use RRAs, as appropriate, in overseeing regulated industry and ensuring the safety and effectiveness of all types of regulated products, supplementing critical oversight tools such as inspections.