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Gottlieb: Device Pre-Cert Pilot May Offer 'Modern' Reg Approach For LDTs

September 29, 2017
FDA Commissioner Scott Gottlieb said the agency's new device pre-certification pilot program offers a “modern approach to regulation” that could be applied across the agency, including to laboratory-developed tests (LDTs). “This pre-cert framework is a modern approach to regulation -- focusing on the product developer rather than just the product -- that could have other applications across our portfolio. For example, this construct could form part of the framework for a modern legislative approach to laboratory-developed tests,” he said. But...

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