FDA Issues Draft Guidance On Devices With Multiple Functions

On April 27, 2018, FDA issued draft guidance on the regulation of devices with multiple functions. The draft guidance implements a requirement of the 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, prohibiting FDA from directly regulating non-"device" software functions in digital health products. FDA did not limit the scope of the draft guidance to cover only the Cures Act mandate, however. Instead, the draft guidance addresses any type of product that includes both device and other functions, regardless of whether those functions involve software. Therefore, any manufacturer of a product that includes both FDA-regulated device functions and non-FDA-regulated functions should be familiar with the draft guidance.