Lexology July 30, 2020
On July 28, the U.S. Food and Drug Administration (FDA) issued the final guidance “Multiple Function Device Products: Policy and Considerations,” which describes FDA’s regulatory approach and policy for products with multiple functions (either hardware- or software-related) that include at least one medical device function and one “other” non-medical device function. This finalizes FDA’s April 2018 draft guidance, summarized here, which built on changes enacted by the 21st Century Cures Act (Cures Act), focusing on the impact of unregulated functions on regulated functions built into the same software or hardware device for use in the United States. In the analysis below, we assess key changes in the finalized version of the guidance, and compare FDA’s approach to the one adopted...
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