FDA Tells Congress it is Mulling Strategies to Regulate DTC Genetic Tests as Medical Devices | GenomeWeb

Originally published July 23.

By Turna Ray

WASHINGTON, DC – At a congressional hearing on direct-to-consumer genomic testing this week, the US Food and Drug Administration stated unequivocally for the first time that it considers the tests marketed by these firms to be medical devices requiring the agency's clearance or approval. Furthermore, a high-ranking FDA official acknowledged that the agency has waited too long to take action against this rapidly growing industry.

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