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  5. Webinar - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Final Guidance - 11/14/2019 - 11/14/2019
  1. Workshops & Conferences (Medical Devices)

Webcast

Event Title
Webinar - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Final Guidance
November 14, 2019


Date:
November 14, 2019
Time:
02:00 PM - 03:30 PM EST
Organized By:
Organizer

Summary: On November 14, 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 Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act final guidance.

Background: Section 3060(a) of the 21st Century Cures Act (Cures Act) amended Section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) on December 13, 2016, removing certain software functions from the definition of device in Section 201(h) of the FD&C Act. This final guidance provides FDA's current thinking regarding the amended device definition and the resulting effect the amended definition has on the FDA's guidances related to medical device software.

Webinar Details: Registration is not necessary.

Date: November 14, 2019

Time: 2:00 p.m. to 3:30 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:

  • 1-888-780-9649
  • Conference Number: PWXW9584733
  • Passcode: 2179630

International Callers Dial:

  • 1-630-395-0306
  • Conference Number: PWXW9584733
  • Passcode: 2179630

To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW9584733&p=2179630&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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