U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. Medical Devices News and Events
  4. Workshops & Conferences (Medical Devices)
  5. Webinar - Clinical Decision Support Software Final Guidance - 10/18/2022
  1. Workshops & Conferences (Medical Devices)

Webcast

Event Title
Webinar - Clinical Decision Support Software Final Guidance
October 18, 2022

Date:
October 18, 2022
Time:
1:00 PM - 2:15 PM ET

Summary

On October 18, 2022 the FDA hosted a webinar for industry and interested stakeholders to discuss and answer questions about the Clinical Decision Support Software final guidance. The final guidance:

  • Clarifies the scope of the FDA's oversight of clinical decision support (CDS) software intended for health care professionals as medical devices.
  • Clarifies that the FDA's existing digital health policies continue to apply to software functions that meet the definition of a medical device, including those that are intended for use by patients or caregivers.
  • Provides examples of non-device CDS functions and device software functions.

Background

The Food and Drug Administration (FDA) has long regulated software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including software that is intended to provide decision support for the diagnosis, treatment, prevention, cure, or mitigation of diseases or other conditions (often referred to as clinical decision support software). This guidance clarifies the scope of the FDA's oversight of clinical decision support software intended for health care professionals (HCPs) as devices. Not all clinical decision support software used in healthcare settings are medical devices and therefore subject to FDA oversight as a device.

Webinar Details

Registration is not necessary.

Date: October 18, 2022

Time:

  • 12:45 ET: To ensure you're connected, please join by this time.
  • 1:00 – 2:15 ET: Live Program

Please dial in 15 minutes before the start of the webinar to allow time to connect.

Please click the link below to join the webinar:
https://fda.zoomgov.com/j/1607287513?pwd=cjFMVWFlYjJEd29QcFBvZTMvamVDZz09

Passcode: $5jTYB

Please note: Participants who join the webinar using the Zoom webinar link above should use computer audio (listen through their computer speakers and speaking through computer microphone/headset).

The dial-in information provided below is for participants who will be joining the webinar by phone only.

Webinar Materials

The presentation, printable slides, and transcript are available at CDRH Learn under "Specialty Technical Topics", sub-section "Digital Health."

If you have questions about this guidance document, please contact the CDRH Digital Health Center of Excellence at [email protected]. If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at [email protected], 1-800-638-2041, or 301-796-7100.

Back to Top