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Kathryn Culver is an associate in the firm’s Los Angeles office and a member of the Food, Drug, and Device Practice Group. Ms. Culver advises pharmaceutical, biotechnology, and medical device companies on FDA regulatory and compliance issues.

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