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

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.

Diagnostics regulatory reform draft legislation being considered by a House subpanel would not result in more accurate and effective laboratory developed tests (LDTs), or even streamline any new molecular-based diagnostics’ passage to market, both FDA’s Jeffrey Shuren and CMS’ Patrick Conway argued before the House Energy and Commerce Health Subcommittee on Nov. 17.

Instead, the two officials told Subcommittee Chairman Joe Pitts, D-Pa., that the House proposal

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