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CMS And FDA Stand Together Behind FDA Oversight Of LDTs At House Hearing

This article was originally published in The Gray Sheet

Executive Summary

CMS Deputy Administrator for Innovation and Quality Patrick Conway and FDA Device Center Director Jeffrey Shuren told a House subcommittee that legislators’ efforts to replace FDA’s proposed laboratory-developed test framework would lead to duplicative, time-consuming, expensive regulation, and could only result in ineffective and delayed diagnostics that might harm patients.

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