Lexology August 18, 2020
Covington & Burling LLP

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...

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