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FDA Releases LDT Regulatory Framework, Notification Draft Guidances

Two promised draft guidances on FDA’s framework for regulating laboratory developed tests and notification and medical device reporting requirements for LDTs have been posted. The agency wants swift notification from labs for most available LDTs once a framework is finalized.

FDA followed through with its promise to officially issue its proposals to regulate laboratory-developed tests as soon as possible under congressional notification requirements with the Sept. 30 posting of two draft guidances.

One of the document outlines the agency’s planned regulatory framework for LDTs and the other more specifically describes...

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