FDA Vs Congress The Software Showdown
September 2022 will be remembered as a seminal turning point in digital health in the U.S. With the FDA’s final guidance on Clinical...
Source: meddeviceonline.com
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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
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...
Source: jdsupra.com
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...
Source: jdsupra.com
Coverage Of FDA's AI/ML Medical Devices Workshop - Part 2: FDA's Recent Digital Health Initiatives - Food, Drugs, Healthcare, Life Sciences
In our last post, we took a brief look back through history at FDA's approach to regulating medical device software and found that there is little distinction from the agency's approach to hardware devices.
Source: mondaq.com
A Discussion of FDA's AI/ML Medical Devices, Part II
FDA announced several digital health initiatives aimed at improving the agency’s resources and policies governing software and data systems. We will review FDA’s digital health improvement highlights and take a quick look at AI/ML-enabled medical devices.
Source: natlawreview.com