CHA News

FDA Must Consider Alternatives to Laboratory Developed Test Proposals

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What’s Happening: CHA submitted comments to the Food & Drug Administration (FDA) on proposed regulation of laboratory developed tests (LDTs).  

What Else to Know: The proposed rule would have significant unintended consequences for the delivery of medical laboratory services and would raise costs to the overall health care system.  

In the letter, CHA urges the FDA to revise its proposed rule and consider alternative approaches, such as the continued enforcement discretion of LDTs, which take into account the unique role of hospital and health system laboratories in ensuring the availability of timely, high-quality, and cost-effective diagnostics in the hospital setting.