The Biden administration has proposed to extend medical-device oversight to laboratory developed tests. But doing so could increase compliance costs for test developers and reduce patient access to widely used tests, according to Susan Van Meter, President of the American Clinical Laboratory Association. She joins Bloomberg Intelligence analyst Duane Wright on this episode of the Votes & Verdicts podcast to discuss how the FDA’s existing framework for regulating medical devices is ill-suited for LDTs, why the Biden proposal should be withdrawn and a legislative approach to modernizing oversight of all clinical lab tests, including LDTs.

<p>The Biden administration has proposed to extend medical-device oversight to laboratory developed tests. But doing so could increase compliance costs for test developers and reduce patient access to widely used tests, according to Susan Van Meter, President of the American Clinical Laboratory Association. She joins Bloomberg Intelligence analyst Duane Wright on this episode of the Votes &amp; Verdicts podcast to discuss how the FDA’s existing framework for regulating medical devices is ill-suited for LDTs, why the Biden proposal should be withdrawn and a legislative approach to modernizing oversight of all clinical lab tests, including LDTs.</p>

Votes and Verdicts is a series that examines the intersection of business, policy and law. It features conversations between Bloomberg Intelligence's team of litigation and policy analysts and thought leaders discussing legal and policy issues affecting markets and business decisions across many sectors.

<p>Votes and Verdicts is a series that examines the intersection of business, policy and law. It features conversations between Bloomberg Intelligence's team of litigation and policy analysts and thought leaders discussing legal and policy issues affecting markets and business decisions across many sectors.</p>

Votes & Verdicts

Biden’s Lab-Developed Test Proposal

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