Textbook of Digital Health

Dr Chris Paton

← References

Clinical Decision Support Software: Guidance for Industry and FDA Staff

US Food and Drug Administration (2023)

U.S. Food and Drug Administration.

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software

Abstract. Updated FDA guidance on the clinical evaluation and regulatory considerations for software-based medical devices, supplementing the IMDRF 2017 framework with current FDA expectations for SaMD evidence generation.