New RRA (Remote Regulatory Assessment) guidance clarifies when and how FDA can use remote reviews, what’s voluntary vs. mandatory, and how electronic records and live data access are handled.

Summary

The FDA (US Food and Drug Administration) issued a final guidance, “Conducting Remote Regulatory Assessments—Questions and Answers,” that explains how the agency uses RRAs to evaluate compliance without always entering a facility. The document (finalized June 26, 2025) clarifies what makes an RRA voluntary or mandatory, how FDA will request participation, and how it manages electronic records access, live data viewing, and confidentiality/security. The guidance applies across FDA-regulated products and is intended to make oversight more consistent post-pandemic. Final guidance. (U.S. Food and Drug Administration)

What happened

• FDA published the final RRA Q&A guidance and corresponding Federal Register notice outlining the agency’s current thinking and the key updates from the 2024 draft, including clearer distinctions between mandatory vs. voluntary requests and expectations for informed consent in voluntary RRAs. Guidance page • Federal Register notice. (U.S. Food and Drug Administration)
• FDA updated its public Remote Oversight Tools hub to reflect the final guidance and its role across all centers (drugs, biologics, devices, and more). Remote Oversight Tools. (U.S. Food and Drug Administration)

What’s new in the final guidance

• Voluntary vs. mandatory RRAs: FDA spells out when establishments must participate (e.g., when conducted under specific statutory authorities) versus when participation is requested and voluntary, and how terms are communicated. Federal Register summary. (Federal Register)
• Electronic records & live data: Clarifies mechanisms for electronic records review and circumstances for live data access, including expectations for secure connections and audit trails. Federal Register summary. (Federal Register)
• Confidentiality & security: Addresses how FDA protects establishment information during RRAs, with references to FOIA handling and redactions. Final PDF. (U.S. Food and Drug Administration)
• Not an “inspection”: The guidance reiterates that RRAs are not inspections under FDCA (Federal Food, Drug, and Cosmetic Act) §704; they’re a separate oversight tool that can precede or follow inspections. Law firm overview. (Sidley Austin)

Key numbers and dates

• June 26, 2025: Final guidance issued; replaces the January 2024 revised draft. Guidance page. (U.S. Food and Drug Administration)
• Post-pandemic toolkit: FDA positions RRAs as a permanent part of its oversight toolbox for FDA-regulated products. Remote Oversight Tools. (U.S. Food and Drug Administration)

What to watch next

• Use in application reviews: FDA notes RRAs may support timely review of marketing submissions (e.g., to evaluate records remotely). Watch for case studies in pre-approval contexts. Guidance analysis. (Arnold & Porter)
• Center-specific playbooks: Additional center or program updates (e.g., drugs, biologics, devices) that standardize RRA requests, technical specs, and documentation. Federal Register summary. (Federal Register)

Why this matters for you

Study sponsors, manufacturers, and quality leaders can expect more frequent RRA requests to verify records, training, and batch history without the travel and lead time of on-site inspections. Preparing RRA-ready document rooms, secure portals, and plain-English SOPs (standard operating procedures) for live data access can reduce delays and help teams respond quickly.

Digital and compliance teams should align now on secure connectivity, user permissions, logging, and confidentiality protocols for remote document sharing and screen-sharing. Build simple checklists for voluntary vs. mandatory requests, define who consents to terms for voluntary RRAs, and track outcomes just as you do for inspections—so the evidence is ready for auditors and future submissions.

Primary sources:

• FDA final guidance: Conducting Remote Regulatory Assessments—Questions and Answers. (U.S. Food and Drug Administration)
• Federal Register notice: Availability of final guidance and key updates. (Federal Register)
• FDA hub: Remote Oversight Tools. (U.S. Food and Drug Administration)