Town Hall – Clinical Decision Support Software, Final Guidance March 11, 2026

https://www.fda.gov/medical-devices/medical-devices-news-and-events/town-hall-clinical-decision-support-software-final-guidance-03112026?utm_medium=email&utm_source=govdelivery The U.S. Food and Drug Administration (FDA) will host a town hall for industry and other interested parties to discuss updates to the Clinical Decision Support Software, Final Guidance, issued on January 6, 2026, and re-issued on January 29, 2026. This guidance clarifies the FDA’s thinking on the types of clinical decision support (CDS) software functions that are excluded from the definition of device by the criteria in section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act. This guidance further clarifies that the FDA’s existing digital health policies continue to apply to software functions that meet the definition of device, including those that are intended for use by patients or caregivers. Dates: March 11, 2026 Time: 1:00 – 2:00 p.m. ET Registration is not required. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software?utm_medium=email&utm_source=govdelivery Clinical Decision Support Software Guidance for Industry and Food and Drug Administration Staff January 2026