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FDA Outlines Proposed Framework for Regulating Artificial Intelligence Software

In a recent post on the Covington Digital Health blog, we analyze FDA’s recently-released proposed regulatory approach for medical devices that use artificial intelligence (AI) and machine learning (ML), which we refer to here as the “AI Framework.” The AI Framework does not establish new requirements or an official policy, but rather was released by FDA … Continue Reading

FDA Issues Final Guidance Establishing Framework for a Safety and Performance Based Pathway

On February 1, 2019, FDA issued a final guidance[1] establishing an optional 510(k) pathway for certain well understood devices. This “Safety and Performance Based Pathway,” an expansion of the longstanding Abbreviated 510(k) program, is part of FDA’s ongoing effort to modernize and strengthen the 510(k) program. The pathway will continue to require the identification of … Continue Reading

FDA Issues New Draft Guidance on Class Labeling of Companion Diagnostics for Oncology Therapeutic Products

On December 6, FDA Commissioner Gottlieb announced in a press release the availability of a new draft guidance entitled, “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products” (Draft Guidance). The agency also published the Draft Guidance announcement in the December 7 Federal Register. FDA issued … Continue Reading
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