Chip-based genetic predisposition tests among most likely candidates for FDA regulation, staffers say.
This article was originally published in The Gray Sheet
GENETIC TESTS BASED ON CHIP TECHNOLOGY ARE PRIME CANDIDATES FOR FDA REGULATION, agency staffers say. FDA has yet to formulate a policy on the genetic predisposition testing field, but if it does move to impose regulations, chip-based technologies would be a more likely target for regulation because they can be mass marketed to labs in a manner similar to test kits and analyzers.
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