Hi everyone!
Wanted to flag that FDA will be hosting their inaugural Digital Health Advisory Committee meeting on November 20-21 (in person and virtual).
The advisory committee will discuss-
- total product lifecycle considerations for generative artificial intelligence (AI)-enabled medical devices;
- how the use of generative AI-may impact safety and effectiveness of medical devices enabled with this technology; and
- premarket performance evaluation, risk management, and postmarket performance monitoring for generative AI-enabled devices.
More information on the meeting (material and webcast information) can be found here: LINK
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John Diaz-Decaro
ModernaTX, Inc.
Cambridge MA
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