The U.S. FDA’s remote regulatory assessment (RRA) program, the subject of a guidance the agency finalized in June 2025, is proving to be one of the trickier bits of navigation for makers of devices, drugs and biologics. RRAs were on tap at the 2025 enforcement conference held by the Food and Drug Law Institute, but the session seemed to suggest that industry may not be fully prepared for how the agency will conduct these reviews, but also what it will do with the results.