FDA Keeping All Ideas in Play in Soliciting Public Comments on LDT Regulation

According to one high-ranking FDA official, the agency is considering downgrading in risk classification certain regulated tests as a way to manage its limited resources; phasing in regulation of LDTs that aren't currently regulated; collaborating with the NIH to develop a test registry that could serve FDA's purposes for keeping an eye on all test developers; and possibly enlisting the help of third-party inspectors to help the agency with its increasing regulatory burden.

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