Lessons From FDA Draft Guidance On Multifunctional Devices

By Gregory Levine and Abram Barth (May 23, 2018, 1:58 PM EDT) -- On April 27, 2018, the U.S. Food and Drug Administration issued draft guidance on the regulation of devices with multiple functions. The draft guidance implements a requirement of the 21st Century Cures Act, signed into law on Dec. 13, 2016, prohibiting FDA from directly regulating non-"device" software functions in digital health products. The FDA did not limit the scope of the draft guidance to cover only the Cures Act mandate, however. Instead, the draft guidance addresses any type of product that includes both device and other functions, regardless of whether those functions involve software.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a product that includes both FDA-regulated device functions and non-FDA-regulated functions should be familiar with the draft guidance....

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