Aug 3, 2020

The US Food and Drug Administration (FDA) issued a final guidance on its regulatory approach to multiple function device products, defined as products that have at least one device function and one non-device function (“other function”).​ We reported on the draft version of this guidance when it was published in 2018.

Federal law and FDA policy on multiple function device products

Section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides the definition of a device, and a “device function” is any function of a product that meets this definition. (A function is taken in this guidance to mean “a distinct purpose of the product, which could be the intended use or a subset of the intended use of the product.” Passed in 2016, the 21st Century Cures Act added section 520(o) to the FD&C Act, excluding certain software functions from the definition of a device. It also stated that in the case of a product with at least once device function and one non-device software function, the FDA may assess the impact of the non-device function on the device function in terms of the product’s safety and effectiveness.

While the FD&C Act deals specifically with non-device software functions, the FDA takes the position that this policy should apply to all multiple function device products, regardless of whether the “other function” under consideration is software- or hardware-based.

Guidance document explains policies applied to FDA review

The guidance document lays out how the FDA intends to assess the impact of “other functions” on the safety and effectiveness of a device function that is subject to agency review. Detailed considerations for assessing “other functions” are provided, along with recommendations for labeling, device hazard analysis, and performance testing as part of premarket submissions. 

The document also includes a discussion of modifications to “other functions” and post-market requirements. An appendix provides a list of examples of multiple function device products, along with explanations illustrating how the policies outlined in the guidance would be applied to these products.

Related US FDA medical device and IVD regulatory resources:

Author

  • Timothy Herr

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