Study Finds FDA Relied on Flawed Data When Approving High-Risk Medical Devices for Obstetrics and Gynecology; Are There Implications for Regulation of LDTs?

Jul 27, 2016 | Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations

Researchers suggest FDA approvals be based on more rigorous clinical studies before and after medical devices get approved to market Do regulators consistently get it right when reviewing medical devices and clinical laboratory tests as part of the market-approval process? New findings provide credible evidence that government regulators have their own problems when reviewing submissions for market clearance. One example involves researchers at the Northwestern University Feinberg School of...
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