Draft Framework Would Increase FDA's Laboratory-Developed Test Oversight

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Draft Framework Would Increase FDA's Laboratory-Developed Test Oversight

Dennis Tosh

Guide to Medical Device Regulation

August 5, 2014 at 05:57 AM EST

Laboratory-developed tests (LDTs) — in vitro diagnostic (IVD) tests that are designed, manufactured and used within a single laboratory — would be subject to dramatically more oversight by the FDA under a draft “framework for regulatory oversight” released July 31. The draft framework “describes FDA’s priorities for enforcing premarket and postmarket requirements for LDTs as... Read More

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Draft Framework Would Increase FDA's Laboratory-Developed Test Oversight

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