On July 28, 2020, FDA announced the publication of a final guidance on Multiple Function Device Products: Policy and Considerations that outlines FDA’s evolving approach to the regulation of multiple function device products, including software.
The concept of “multiple function” products was introduced by the 21st Century Cures Act (“Cures Act”) of 2016, which added section 520(o) to the FD&C Act. Multiple function device products are those with multiple functions that each have a distinct purpose in the product (e.g., collection, storage, analysis) where only certain functions are actively regulated by FDA. With regard to software, section 520(o) of the FD&C Act gives FDA the authority to review the non-device function(s) of a multiple function device product to assess the impact of the non-device function(s) on the device function(s).
Here are the key takeaways on FDA’s newly-issued final guidance:
- While the Cures Act language distinguishes device functions from non-device functions, FDA adopts a final policy that distinguishes between device functions and other FDA says that “other functions” include not only non-device functions, but also device functions that are exempt from premarket review (i.e., 510(k)-exempt), as well as device functions that fall within FDA’s exercise of enforcement discretion.
- The same approach should apply to FDA’s assessment of all multiple function device products, whether software, hardware or both.
- For multiple function device products, manufacturers should perform impact assessments for all “other functions” to assess any effects of the other functions on the device functions of the product – reaching a conclusion of no impact, positive impact, or negative impact. These assessments should be documented as part of the device’s design validation process. In the event that an impact is found, the extent of the impact should be evaluated and included in the manufacturer’s hazard analysis.
- FDA expects that impact assessments be included as part of a premarket submission when there is a (i) negative impact or (ii) positive impact that the manufacturer seeks to include in the product’s labeling. For a finding of no impact or a positive impact that the manufacturer does not seek to include in the product’s labeling, FDA does not expect to see the impact assessment as part of the premarket submission, although FDA may review the documentation as part of an inspection.
- FDA broadly defines a potential “negative” impact of an “other function” on the device function(s). Thus, as a practical matter, it is likely that it will be difficult for a manufacturer to conclude that the “other functions” have no impact on the device function. We anticipate that manufacturers will need to submit impact assessments for a large number of multiple function device products.
- One open question is the possible impact of FDA determining that a company failed to submit an impact assessment that, in FDA’s view, was required as a part of the premarket review of a multiple function device product. For example, if a company makes a good faith determination that a non-device function has no impact on the device functions of a multiple function device product, and submits a 510(k) or PMA without an impact assessment, but FDA later disagrees with that determination, would the agency take the position that the 510(k)/PMA was ineffective and not properly obtained? Similarly, would FDA exercise enforcement discretion in such a situation to allow the company to keep the product on the market while it submits the impact assessment and other documentation associated with the non-device functions?
To help companies navigate these issues, FDA’s guidance provides several case studies of multiple function device products and what FDA would expect to see as part of a premarket submission for the device functions. Companies developing multiple function device products will want to ensure that they consider all aspects of the FDA’s final guidance.