Lexology April 4, 2023
The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).[1] This significant step signals FDA’s intent to provide a forward-thinking, least burdensome approach to support the development of safe and effective medical devices that use machine learning-enabled device software functions (“ML-DSF”).
The Food and Drug Omnibus Reform Act of 2022 added Section 515C to the Federal Food, Drug, and Cosmetic Act (“FDCA”). This new section provides FDA with the authority to review and authorize Predetermined Change Control Plans (“PCCPs” or “Plans”) for medical devices.[2] Under FDCA § 515C, if a PCCP for a device is authorized by FDA as part of an underlying...
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