Lexology October 15, 2025
The U.S. Food and Drug Administration (FDA) has published its guidance agenda for Fiscal Year 2026, announcing plans for eight guidance documents to be released this upcoming year. It also named 12 guidance documents that the agency says it intends to publish “as resources permit.” Below we discuss which forthcoming FDA guidances may be most important for medical device companies, outlining how the agency said it will issue guidance on topics including artificial intelligence, real-world evidence, 510(k) submissions, patient preference information, quality management systems, and devices that aim to assist with weight loss, surgery, and mental health.
FDA’s Center for Device and Radiological Health (CDRH) posted its updated guidance agenda for Fiscal Year 2026, including an “A” list prioritizing the...
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