FDA device center outlines FY 2027 guidance plan, targeting AI-enabled devices and change-control plans
read at raps ↗RegulatoryNeutral
On Oct 1, the FDA’s Center for Devices and Radiological Health announced its guidance agenda for fiscal year 2027.
The top priority is finalizing guidance for artificial intelligence-enabled medical devices throughout their product lifecycle.
The agency also aims to issue guidance on pre-determined change control plans, which outline how manufacturers can manage modifications.
CDRH expects to release a total of 11 final guidance documents and three draft guidances during the year.
source
This writeup was produced by pharmadog from original reporting by raps.
Original headline: “This Week at FDA: No Overton vote until after midterms, FDA signals advisory committee support, and more”
read at raps ↗76 words · retrieved 1h ago
comments(0)
5-min edit window · permanent after that