News Brief: FDA Finalizes Guidance on Remote Regulatory Assessments

On Thursday, June 26, 2025, the U.S. Food and Drug Administration (FDA) issued a final guidance for industry titled “Conducting Remote Regulatory Assessments—Questions and Answers,” which was originally announced January 26, 2024. This document outlines the FDA’s current perspective on the use of Remote Regulatory Assessments (RRAs) and addresses common questions about their implementation. During the Covid-19 pandemic, RRAs benefited the FDA as a tool to maintain oversight, manage risks, support urgent public health needs, and assess the compliance of FDA-regulated products with relevant regulatory standards.

The final guidance distinguishes between voluntary and mandatory RRAs. Mandatory RRAs apply in specific circumstances—such as those authorized under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act for drug manufacturers, and under certain provisions of the Foreign Supplier Verification Program for food importers. In those cases, regulated entities must comply with the request. In contrast, the FDA may request to conduct voluntary RRAs at its discretion, typically as a tool to gather information, assess compliance or verify corrective actions. Although voluntary, the refusal to participate may prompt the FDA to initiate a traditional on-site inspection instead.

This guidance illustrates the FDA’s move toward a more risk-based and technology-enabled regulatory system. RRAs provide the FDA with more flexibility to oversee domestic and foreign facilities, prioritize resource allocation, and respond more efficiently to emerging risks. The implementation of RRAs into the FDA’s practices marks a significant step in modernizing regulatory oversight and reflects lessons learned during the COVID-19 pandemic.

For more information on the final guidance, click here.