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FDA Releases Draft Guidance on Use of Remote Regulatory Assessments

The guidance covers voluntary and statutorily authorized RRAs, but does not change the core requirements of inspections and pre- and post-market authorities.

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The FDA has released a draft guidance on the expanded use of remote regulatory assessments (RRAs) and how it intends them to be incorporated consistently across all FDA-regulated products. The remote assessments of FDA-regulated establishments and/or their records can help determine compliance with applicable FDA requirements, inform regulatory decisions, and verify information submitted to the agency.

The draft guidance, “Conducting Remote Regulatory Assessments Questions and Answers,” provides transparency to stakeholders about how RRAs may be used and to promote consistency in the way they are conducted. It covers voluntary and statutorily authorized RRAs, but does not change the core requirements of inspections and pre- and post-market authorities. Except for RRAs for establishments required to comply with the Foreign Supplier Verification Programs (FSVP) regulation, an RRA does not function as an inspection.


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The FDA will continue to use RRAs, as appropriate, according to a risk-based approach that best protects public health, such as when it is unable to deploy in-person staff due to travel restrictions. RRAs may also be used to assess establishments identified in product applications when these establishments have a prior history of compliance. Where appropriate, RRAs allow the FDA to review information, such as livestreams and records, provided by a company without going on-site.

As part of the FDA’s Fiscal Year 2023 budget request, the agency has requested additional authorities to expand the ability to use remote regulatory tools across all commodities. The agency currently relies on voluntary cooperation for the use of these tools for non-drug establishments or when the RRA does not involve assessing a food importer’s compliance with FSVP.


 


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