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  5. Webinar - Clinical Decision Support Software: Draft Guidance - 11/04/2019 - 11/04/2019
  1. Workshops & Conferences (Medical Devices)


Event Title
Webinar - Clinical Decision Support Software: Draft Guidance
November 04, 2019

November 04, 2019
12:00 PM - 01:30 PM EST
Organized By:

Summary: On November 4, 2019, the U.S. Food and Drug Administration (FDA) will host a webinar for device manufacturers and industry to discuss and answer questions about the Clinical Decision Support Software draft guidance.

Background: The purpose of this draft guidance is to describe FDA's regulatory approach to clinical decision support (CDS) software functions. The agency's approach includes recent changes to the FD&C Act made by the 21st Century Cures Act (Cures Act), which amended Section 520 and excludes certain software functions from the device definition.

This draft guidance clarifies the types of CDS software functions that:

  • Do not meet the definition of a device as amended by the Cures Act;
  • May meet the definition of a device but for which, at this time and based on our current understanding of the risks of these devices, the FDA does not intend to enforce compliance with applicable device requirements of the FD&C Act, including, but not limited to, premarket clearance and premarket approval requirements; and
  • Meet the definition of a device and on which the FDA intends to focus its regulatory oversight

Webinar Details: Registration is not necessary.

Date: November 4, 2019

Time: 12:00 p.m. to 1:30 p.m. EST.  To ensure you are connected, please dial in 15 minutes prior to the start of the webinar.

NOTE: You must dial-in to hear the presentation and ask questions.

U.S. Callers Dial:

  • 1-888-972-9927
  • Conference Number: PWXW9584730
  • Passcode: 6832800

International Callers Dial:

  • 1-773-756-4791
  • Conference Number: PWXW9584730
  • Passcode: 6832800

To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW9584730&p=6832800&t=c

Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/CDRHWebinar

We appreciate your feedback on our webinar program. Following the webinar, we will provide a link to a short survey about your webinar experience, which should take no more than 5-10 minutes to complete. Your responses are confidential and will be used to help ensure the quality of our CDRH webinar program.

NOTE: The FDA does not provide Continuing Education (CEU) or Certificates of Attendance for webinar attendance.

If you have any questions, please contact the Division of Industry and Consumer Education.

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