Multiple Function Device Products: Policy and Considerations

On 29 July 2020 the FDA issued the final guidance for industry and FDA staff.

Medical products may contain several functions, some of which are subject to FDA's regulatory oversight as medical devices, while others are not. Products with at least one device function and at least one "other function" are referred to in this guidance as "multiple function device products." For purposes of this guidance, for any given product, the term "function" is a distinct purpose of the product, which could be the intended use or a subset of the intended use of the product. This guidance explains FDA's regulatory approach and policy for all multiple function device products. Specifically, this guidance clarifies when and how FDA intends to assess the impact of "other functions" that are not the subject of a premarket review on the safety and effectiveness of a device function that is subject to FDA review. The purpose of this guidance is to identify the principles, premarket review practices, and policies for FDA's regulatory assessment of such products, and to provide examples of the application of these policies.

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