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Patients, Test Makers Ask Lawmakers To Meet On Diagnostics Bill Draft

May 07, 2019
Major lobby groups representing diagnostic test makers wrote to House and Senate committee heads on Monday (May 6) asking them to work with stakeholders and FDA to revise their draft legislation that lays out an approach for FDA to regulate in-vitro clinical tests. The groups have different views on FDA’s purview, but they generally agree that diagnostic tests should be regulated differently than traditional medical devices. The latest draft of the bill appears to adopt many of the technical suggestions...


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