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Webinar: FDA Clinical Decision Support Software Guidance Webinar

February 7 @ 12:00 pm - 1:00 pm

“Acting Director Mr. Brendan O’Leary of the Digital Health Center of Excellence at the FDA will present on the Clinical Decision Support Software, Guidance for Industry and Food and Drug Administration Staff that was issued September 28, 2022. Acting Director O’Leary will provide a general overview of the CDS Guidance to educate and gain further awareness. He will further clarify FDA’s existing digital health policies continuing to apply software functions that meet the definition of a device, including those that are intended for use by patients or caregivers. There will be examples of how FDA applies the Device CDS criteria versus Non-Device CDS.”