FDA Guidance Hikes Oversight Of Clinical Decision Support Software

By Jessica Karins / September 28, 2022 at 2:26 PM
A new FDA document appears to significantly expand the agency’s oversight of software that helps clinicians make decisions about patients’ treatment -- a departure from a 2019 draft guidance that an industry legal expert on medical software described as alarming and said might require congressional intervention. In the guidance, published Tuesday (Sept. 27), FDA says it will consider software that gives providers specific recommendations about the treatment of patients to be a medical device, as well as software that includes...


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