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Over The Counter But Under The Radar: Direct-To-Consumer Genetics Tests And Fda Regulation Of Medical Devices, Lauren B. Solberg

Vanderbilt Journal of Entertainment & Technology Law

Direct-to-consumer genetic tests are laboratory-developed tests that are marketed and sold directly to consumers. They typically do not require a prescription or any other involvement from a consumer's health care provider. Consumers order these tests online and return a specimen, usually a saliva sample, directly to the laboratory. The results are mailed directly to the consumer, and no health care provider or insurance company need ever learn the contents of these results. The FDA does not currently regulate direct-to-consumer genetic tests, though tests for hundreds of different diseases are readily available to the public.

The FDA's approach to regulating genetic …