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Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and ResearchOffice of the Commissioner,Office of Clinical Policy and Programs,Office of Combination ProductsCenter for Drug Evaluation and Research
Medical products may contain several functions, some of which are subject to FDA's regulatory oversight as medical devices, while others are not. Section 3060(a) of the 21st Century Cures Act (Cures Act) amended the Federal Food Drug, and Cosmetic Act (FD&C Act) to add section 520(o), which excludes certain software functions from the definition of device in section 201(h) of the FD&C Act. The Cures Act also states that in the case of a product with multiple functions that contains both a software non-device function and a device function, FDA may assess the impact that the software non-device function has on the device function when assessing the safety and effectiveness of the device function (section 520(o)(2) of the FD&C Act). FDA believes that a similar approach should be used for the assessment of all multiple function device products.
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.
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
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All written comments should be identified with this document's docket number: FDA-2018-D-1339.