FDA Issued Final Guidance on Multiple Function Device Products

On July 29, 2020, the U.S. Food and Drug Administration (FDA) issued the final guidance: Multiple Function Device Products: Policy and Considerations. This final guidance describes the FDA’s regulatory approach and policy for products with multiple functions that include at least one device function and one “other function,” including certain software functions as described in Section 3060(a) of the 21st Century Cures Act. This guidance also clarifies when and how the agency intends to look at the impact of non-regulated functions on the safety and effectiveness of device functions that are subject to the FDA’s review.

Read the Guidance

This final guidance:

Incorporates feedback from public comments to clarify and provide examples that describe the application of FDA’s policy on products with multiple functions.
Discusses 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 of products with multiple functions that include at least one device function.

REMINDER: Upcoming webinar on this guidance

On September 10, 2020, the FDA will host a webinar for stakeholders interested in learning more about the Multiple Function Device Products final guidance. An opportunity will be provided to ask questions about the guidance.