FDA Finalizes Revised Medical Device Quality System Requirements, Issues Remote Regulatory Assessments Guidance

Lexology February 27, 2024
McDermott Will & Emery

The US Food & Drug Administration (FDA) recently issued two critical policies aimed at harmonizing medical device quality requirements with international standards and enhancing medical device regulatory compliance oversight. On February 2, 2024, the FDA issued the first of these policies: a final rule amending the medical device Current Good Manufacturing Practice requirements of the Quality System Regulation (QSR) to align with the ISO 13485:2016 international standard. Notably, the new standard and requirements under the final rule will not take effect until February 2, 2026.

The second policy is a draft guidance regarding remote regulatory assessments (RRAs) to provide information on the FDA’s continued use of RRAs to conduct remote evaluations of FDA-regulated entities. Together, these developments underscore the FDA’s...

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