FDA Draft Guidance on Clinical and Patient Decision Support Software Issued

    View Authors December 2017

    Recently, the US Food and Drug Administration (FDA) published a notice of availability for the Clinical and Patient Decision Support Software – Clinical and Patient Decision Support Software – Draft Guidance for Industry and Food and Drug Administration Staff (Draft Guidance). 

    The Draft Guidance provides clarity on the scope of FDA's regulatory oversight of two important areas: clinical decision support software (CDS) intended for healthcare professionals, and patient decision support software (PDS) intended for patients and caregivers who are not healthcare professionals.