On Dec. 8, 2017, the FDA released the draft guidance, “Clinical and Patient Decision Support Software.” This guidance addresses software for decision support in two categories: one used by Healthcare Professionals, the other used personally by patients and non-health professionals. It provides FDA interpretation of which types of Decision Support Software do not meet the definition of a medical device (as modified in the 21st Century Cures Act), which types may meet the definition, and which types FDA will focus on in terms of regulatory oversight. One key factor is whether the information provided by the software can be independently evaluated by the Clinician. The full guidance is at the link provided. PDF Copy of FDA Guidance
