Companies that manufacture or market direct-to-consumer tests must submit their products for premarketing review and approval by the Food and Drug Administration (FDA), according to a series of warning letters sent by the agency in May and June.
The letters indicate a shift in the FDA's approach to the tests, which previously had been marketed to consumers online with little oversight. But letters indicate that the agency considers the tests medical devices that consumers may use to make medical decisions and as such require premarket approval.
Bridget M. Kuehn. FDA: Gene Tests Need Premarket Approval. JAMA. 2010;304(2):145. doi:10.1001/jama.2010.904