Today the FDA will officially exempt individual genetic risk tests from 501(k) premarket approval with the condition that the company offering the test should have a one-time premarket review of its testing apparatus and at least one test.
In another example of the FDA's revision of regulatory policies for digital health products, Commissioner Scott Gottlieb announced on Nov. 6, 2017, that the agency is extending its precertification model to low-risk direct-to-consumer genetic risk tests.
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