REGULATORY UPDATE: FDA Issues Final Guidance on Remote Regulatory Assessments

The Food and Drug Administration released a final guidance June 26 outlining the agency’s current thinking on the use of remote regulatory assessments (RRAs) and addressing frequently asked questions. This guidance replaces the revised draft issued in January 2024 and incorporates public feedback received during the comment period.

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. The final guidance distinguishes between voluntary and mandatory assessments, explains how the agency communicates terms and obtains consent and details procedures for electronic record review. It also addresses transparency, data confidentiality and security considerations.