- September 10, 2020
On September 10, 2020, the U.S. Food and Drug Administration (FDA) will host a webinar for device manufacturers and other stakeholders regarding the Multiple Function Device Products: Policy and Considerations final guidance. FDA will discuss the guidance and respond to questions.
On July 29, 2020, the FDA issued final guidance: Multiple Function Device Products: Policy and Considerations. This final guidance:
- Incorporates feedback from public comments to clarify and provide examples that describe the FDA's policy on products with multiple functions.
- Describes medical software provisions of the 21st Century Cures Act as part of the FDA's long-term Digital Health Innovation Action Plan.
- Identifies the principles, premarket review practices, and policies for the FDA's regulatory assessment for products with multiple functions that include at least one device function.