Lexology August 19, 2020
On July 29, 2020, the U.S. Food and Drug Administration issued final guidance on the regulation of devices with multiple functions, Multiple Function Device Products: Policy and Considerations (“final guidance”). This guidance, which finalizes a draft issued April 27, 2018, implements a requirement of the 21st Century Cures Act (“Cures Act”) that prohibits FDA from directly regulating non-“device” software functions in digital health products. Like the draft, the final guidance covers more than just software functions, however, and instead addresses all products that include both device and non-device functions. Any manufacturer of a product that includes both device and non-device functions should therefore pay close attention to this guidance.
Key Updates to the Draft Guidance
The final guidance is largely similar to...