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Guidance Issuing OfficeCenter for Devices and Radiological Health
Medical products may contain several functions, some of which are subject to FDA’s regulatory oversight as medical devices, while others are not. 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. Products with at least one device function are referred to as “multiple function device products.” This draft guidance explains FDA’s regulatory approach and policy for all multiple function device products.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 subject to FDA review. The purpose of this draft guidance is to identify the principles, premarket review 108 practices, and policies for FDA’s regulatory assessment of such products and to provide 109 examples of the application of these policies.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2018-D-1339.