FDA Cracks Down on DTC Genetic Testing | GenomeWeb

The blogosphere is buzzing with the news that the FDA is finally cracking down on direct-to-consumer genetic tests, treating them as if they were medical devices and informing companies that sell them that they are selling medical devices without FDA approval. The New York Times' Andrew Pollack says the FDA has sent letters to five companies last week, saying they must have regulatory approval before selling the DTC tests.

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