On Nov. 8, 2017, the Food and Drug Administration (FDA) published two final orders and a notice related to direct-to-consumer (DTC) genetic tests with potentially important implications for developers of such tests. One of the orders
, issued under new authority provided by the 21st Century Cures Act, finalizes the exemption from Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FDCA) Autosomal Recessive Carrier Screening Gene Mutation Detection Systems; FDA had proposed to exempt these tests after its landmark de novo authorization of 23andMe’s Personal Genome Service. The other order
codifies FDA de novo authorization concerning 23andMe’s Genetic Health Risk (GHR) Assessment Systems (GHR Order). The notice, Exemptions from Premarket Notification for Class II Devices
, proposes and seeks comments on a simplified path to market for Genetic Health Risk (GHR) genetic tests under which, according to an FDA statement, manufacturers of these tests “would have to come to FDA for a one-time review to ensure that they meet the FDA’s requirements, after which they may enter the market with new [genetic health risk] tests without further review.” The notice also proposes to exempt four other class II devices from 510(k).