Pathways' Pick of the Week: FDA Petitioned to Rescind Software Guidance

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An industry coalition has petitioned FDA to rescind and repropose its Clinical Decision Support Software guidance. Excerpted from Pathways’ Picks February 8: MEDCAC Meeting, Software Petition, and More.

FDA’s September 2022 Clinical Decision Support Software guidance represents “an end run” around Congress and should be rescinded and reproposed to align with federal law, according to a petition submitted to the agency February 6. The petition comes from the Clinical Decision Support Coalition, an unnamed alliance of software developers and other stakeholders led by attorney Brad Thompson. The guidance contains multiple provisions to delineate when CDS software crosses the line into being a regulated medical device that go beyond statutory language from the 21st Century Cures Act, the coalition states, aligning with an argument made by multiple attorneys after the guide was published. FDA has argued that the guidance creates no new standards for deciding whether CDS software is a device. The agency acknowledged acceptance of the petition, but there is no specific timeline for it to provide a substantive response.


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