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Page 2 - Software Precertification Pre News Today : Breaking News, Live Updates & Top Stories | Vimarsana

FDA to regulate more AI & software tools as devices, guidance indicates - FDA also seeks new digital health regulatory paradigm in Pre-Cert Program report | Hogan Lovells

In the waning days of FDA’s fiscal year, the U.S. Food and Drug Administration (FDA) issued the greatly anticipated final guidance “Clinical Decision Support Software,” which aims to.

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FDA Changes Direction in Final CDS Guidance | Akin Gump Strauss Hauer & Feld LLP

FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation - Key Points - The Final Guidance does.

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