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PubMed

How Will the Food and Drug Administration Regulate Generative AI-Enabled Medical Devices?

PMID: 42989439 ·

S, i, m, o, n, , S, p, i, c, h, a, k

JournalJournal of medical Internet research
Year
PMID42989439

Abstract

As the US Food and Drug Administration works to develop specific guidelines for the regulation of AI-enabled medical devices, could a previously cleared tool provide some clues as to what the new guidance will look like? In this News and Perspectives article, JMIR Correspondent Simon Spichak reports on and speaks with experts about the UpDoc diabetes management app and the future of AI regulation as AI-enabled devices continue to evolve.

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