On July 28th, the FDA issued the final guidance pertaining to multiple function device products (MFDPs). Products may include several functions and the FDA is now in the process of accommodating for such devices, which can get complicated.
MFDPs are products with one device function and at least one “other function,” which may or may not be considered a medical device—for example, a product has an additional software function like patient management. The term “software,” as it relates to a product’s functions, should not be considered synonymous with the term “medical device.” Therefore, when a product has a medical device function and a software function it is considered a MFDP. As specified in section 3060(a) of the 21st Century Cures Act (December 2016), which amended the Federal Food, Drug, and Cosmetic Act, software functions might acquire, process, analyze, or interpret medical information.
The final guidance will be used to identify the “principles, premarket review practices, and policies for FDA’s regulatory assessment of MFDPs.” In the guidance, the FDA clarifies how they intend on assessing the impact that function(s)—which may not be the subject of a premarket review—have on the medical device functions—which are subject to review. If a product is a hardware device and has a software function, the FDA will consider how the software function impacts the safety and effectiveness of the device function.
The guidance draws on public feedback and hopes to clarify FDA policies regarding MFDPs, providing examples for the applicability of those policies. The following criteria outlines what constitutes as an “other function”:
- Functions that do not meet the definition of a medical device
- Functions that meet the definition of medical device but are not subject to premarket review (e.g. 510(k)-exempt)
- Functions that meet the definition of medical device, but for which FDA has expressed its intention not to enforce compliance with applicable regulatory controls
- Medical device functions, which FDA is conducting a premarket review
In the past, the FDA has focused chiefly on single function device products. The Agency’s 510(k) premarket approval submission process has encouraged manufacturers to produce single device function products via a single predicate and Product Code. With this final guidance, the FDA is taking a step towards an era where a reviewed and approved single MFDP could perform the task of potentially four or more additional functions.
If you would like to learn more about multiple function device products, or need some assistance with getting your MFDP 510(k) ready for submission, please contact the FDA regulatory experts here at MEDIcept.
For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.