The FDA published a draft guidance for multiple function device products that defines the term "function" as "a distinct purpose of the product" that could constitute the entirety of the intended use or a subset thereof. The agency said the objective of the draft is to clarify how it will go about assessing the likely impact of non-device functions on the safety and effectiveness of the product's device function. The draft was prompted by section 3060(a) of the 21st Century Cures Act, which directed the FDA to clarify a number of aspects of medical device regulation for software, and introduces the term "device function-under-review" to the regulatory lexicon. The draft says that the device function-under-review should be designed and implemented separately from the other functions so as to reduce or eliminate dependence of the subject function from the product's other functions. The risk analyses for such products should include the potential impact of the non-reviewed functions on the function under review, and mitigations should be characterized for such risks. The agency is taking comment through June 26 at docket number FDA-2018-D-1339.

No Comments