Town Hall | Virtual
Event Title
Town Hall – Clinical Decision Support Software, Final Guidance
March 11, 2026
- Date:
- March 11, 2026
- Time:
- 1:00 p.m. - 2:00 p.m. ET
Summary
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.
Background
Section 3060(a) of the 21st Century Cures Act (Cures Act), enacted on December 13, 2016, amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to exclude certain medical software functions, including certain clinical decision support software, from the definition of device under section 201(h) of the FD&C Act. 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 FD&C Act (“Non-Device CDS”). This guidance further clarifies that 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. This guidance provides many examples of how FDA intends to consider different kinds of software functions, including Non-Device CDS software functions and device software functions.
Event Details
Registration is not required.
Date: March 11, 2026
Time: 1:00 – 2:00 p.m. ET
Platform: Microsoft Town Hall
If you have questions that you wish to submit for possible discussion during the town hall, please email digitalhealth@fda.hhs.gov . All questions must be received by February 23, 2026, to be considered for the discussion. Questions will not be taken during the live town hall.
Event Materials
After the event, the presentation, printable slides, and transcript will be available on this webpage and at CDRH Learn under “Specialty Technical Topics,” sub-section “Digital Health.”
If you have questions about this town hall, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov , 1-800-638-2041, or 301-796-7100.