Email Updates
Organizational Policy/Guidelines
Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff.
October 3, 2022
Rockville, MD; US Food and Drug Administration: September 28, 2022.
Clinical decision support (CDS) systems must be reliable to be safe. This final guidance outlines CDS scope and software functions used to define their qualification as a device regulated by the US Food and Drug Administration.
