FDA Clinical Decision Support Software Guidance

Deputy Director Mr. Brendan O’Leary of the Digital Health Center of Excellence at the FDA's Center for Devices and Radiological Health presented on the Clinical Decision Support Software, Guidance for Industry and Food and Drug Administration Staff. Deputy Director O’Leary provided a general overview of the CDS Guidance to educate and gain further awareness. He also clarified 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.

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Presenter

Brendan O'Leary

Deputy Director

Digital Health Center of Excellence at the FDA's Center for Devices and Radiological Health

Brendan O’Leary is Deputy Director