the FDA announced the availability of final guidance for industry titled Conducting Remote Regulatory Assessments Questions and Answers. The final guidance describes how FDA will use Remote Regulatory Assessments (RRAs) for FDA-regulated products.

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.

This final guidance follows from a revised draft guidance published in January 2024 which reflected consideration of stakeholder comments on a preceding draft guidance of the same title and revisions to align with changes in law (Food and Drug Omnibus Reform Act, 2022). Among other things, that law made device establishments (in addition to those for drugs) and sites, entities, or facilities subject to bioresearch monitoring inspections subject to mandatory records requests and required FDA to issue guidance on .

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; and
• address concerns about confidentiality and security of information reviewed by FDA.

FDA’s use of RRAs to exercise oversight of FDA-regulated products has generated significant interest from Congress and other interested parties, such as drug, food, and device manufacturers. The guidance lists several benefits of RRAs, including the potential for decreased inspection time and faster regulatory decisions involving product applications and compliance.

The FDA uses a robust, risk-based oversight approach to ensure the continued safety of the nation’s food and medical product supply. RRAs have enabled the agency to provide oversight to as many facilities as possible when travel was restricted while continuing to deploy our resources where possible to protect consumers and patients and promote public health.

For example, throughout the pandemic, the FDA used RRAs, domestically and abroad, for certain FDA-regulated products to help the agency conduct oversight, mitigate risk, and meet critical public health needs when 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. [FDA]