Multiple function device products — FDA clarifies its approach

May 30, 2018By: Adrienne R. Lenz Download PDF

On April 27, 2018 FDA released a draft guidance describing the regulatory approach and policy for multiple function device products. The draft guidance, Multiple Function Device Products: Policy and Considerations, has been issued in response to the 21st Century Cures Act Sec. 3060(a) “Clarifying Medical Software Regulation.”

The term “function” is defined as “a distinct purpose of the product, which could be the intended use or a subset of the intended use of the product.” Draft Guidance at 4.

The draft guidance is intended to clarify how FDA assesses the impact of functions that are not subject to FDA review when they are part of a multi-function product that includes at least one function that is subject to FDA review.

In short, the draft guidance indicates that FDA will not regulate functions of a multi-function product that do not meet the statutory device definition or are devices that are subject to an existing enforcement discretion policy.

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