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BioWorld - Wednesday, February 4, 2026
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Home » FDA’s guidance for clinical decision support draws second request for withdrawal
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FDA’s guidance for clinical decision support draws second request for withdrawal

July 14, 2023
By Mark McCarty
The U.S. FDA’s recent final guidance for clinical decision support (CDS) software has drawn a second citizen’s petition for withdrawal, this time from a law professor at the University of Florida (UF). Barbara Evans of the UF School of Law asserted that the CDS final “raises constitutional issues” that are of sufficient importance to warrant an investigation led by the FDA commissioner’s office because of what she argues is a disregard for the First Amendment encoded in the guidance.
Medical technology Regulatory Software U.S. FDA

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