Press Release/Announcement

Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff

Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff. Rockville, MD; US Food and Drug Administration: Sept 26, 2019.

Clinical decision support (CDS) systems must be reliable to be safe. This draft guidance seeks opinions to define CDS scope and software functions used to define their qualification as a device regulated by the US Food and Drug Administration. The deadline for submitting comments is December 26, 2019.