Lexology February 21, 2024
The Food and Drug Administration (“FDA”) recently issued revised draft guidance on remote regulatory assessments (“RRAs”)—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their records conducted entirely remotely without FDA’s physical presence—signaling confidence and likely greater usage of RRAs to support regulatory decisions and oversight activities.
On January 26, 2024, FDA issued revised draft guidance on RRAs. The draft guidance explains what RRAs are, when and why they may be used, how FDA may conduct them, and differences between voluntary and mandatory RRAs, among other topics.
An RRA is an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely without FDA staff being physically present onsite. FDA utilized RRAs during COVID and intends to...
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