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