Clinical & Patient Decision Support Software; Draft Guidance For Industry & FDA Staff

In this document released on December 8, 2017, the U.S. Food and Drug Administration (FDA) describes planned changes to its oversight of clinical and patient decision support software (CDS). The document provides clarity on the scope of FDA’s regulatory oversight of CDS, including software intended for both health care professionals, caregivers, and health care consumers. This draft guidance is intended to make clear what types of CDS would no longer be defined as a medical device, and thus would not be regulated by the FDA . . .