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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 - Vimarsana News

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...

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

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...