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BioWorld - Wednesday, May 21, 2025
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Home » Torres says regulatory alignment a pressing consideration for AI change control draft
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2022 Medtech Conference

Torres says regulatory alignment a pressing consideration for AI change control draft

Oct. 24, 2022
By Mark McCarty
The U.S. FDA recently released its guidance agenda for fiscal 2023, a plan that de-emphasizes the oft-promised draft guidance for change control for artificial intelligence (AI) algorithms, which is listed as a B priority instead of an A draft guidance priority. At this year’s Medtech Conference here in Boston, the FDA’s Melissa Torres disavowed the notion that any national regulatory authority is delaying another authority’s policy on software change control, but she acknowledged that these conversations about regulatory harmonization typically predate formal policy development.
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