FDA Issues Revised Draft Guidance on Remote Regulatory Assessments Across Regulated Products and Establishments

Lexology January 31, 2024
Covington & Burling LLP

On January 26, 2024, FDA announced the availability of a revised draft guidance explaining its expectations for the use of remote regulatory assessments (RRAs). FDA originally issued the draft guidance for industry, “Conducting Remote Regulatory Assessments Questions and Answers,” in July 2022. This alert has been updated to reflect these revisions.

The draft guidance describes how FDA deployed RRAs during the COVID-19 pandemic to conduct important regulatory oversight activities. Based on this experience, FDA intends to continue to use both voluntary and mandatory RRAs, as applicable, for all types of FDA-regulated products. The draft guidance confirms that FDA views remote assessments as an additional regulatory tool and that RRAs are not generally intended to replace inspections. The draft guidance was...

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