FDA Finalizes Guidance on Remote Regulatory Assessments (RRAs)

The U.S. FDA has released its final Guidance for Industry: Conducting Remote Regulatory Assessments – Questions and Answers, outlining the agency’s framework for using RRAs to oversee FDA-regulated products. Building on a revised January 2024 draft and stakeholder feedback, the guidance reflects updates stemming from the Food and Drug Omnibus Reform Act of 2022, including provisions for device establishments.

Key updates clarify the distinction between voluntary and mandatory RRAs, the process for obtaining consent, and how participation terms are communicated. The guidance also aims to standardize RRA use, outline electronic record review protocols, and address data confidentiality and security.

RRAs involve remote evaluations of establishments or records using tools like remote records access, live video, screen sharing, and teleconferencing. Introduced widely during the COVID-19 pandemic, RRAs proved effective and will continue to supplement on-site inspections, helping ensure product quality and regulatory compliance across all FDA-regulated sectors.

16-07-2025