U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. 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. 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

Webinar Materials

Summary: On November 14, 2019, the U.S. Food and Drug Administration (FDA) held 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.