FDA device center outlines FY 2027 guidance agenda, focusing on AI devices and change control plans
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The FDA's Center for Devices and Radiological Health announced its guidance priorities for fiscal year 2027 on Oct 1.
The top items are finalizing guidance on artificial intelligence‑enabled medical devices throughout their lifecycle and on pre‑determined change control plans (PCCPs).
The center aims to publish a total of 11 final guidance documents and three draft guidance documents during the fiscal year.
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This writeup was produced by pharmadog from original reporting by raps.
Original headline: “FDA’s device center releases guidance agenda for FY 2027”
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