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    October 31, 2023  

    Robert M. Califf, M.D.
    Food and Drug Administration
    10903 New Hampshire Ave.
    Silver Spring, MD 20993

    Re: Request for an extension to the comment deadline to the Rulemaking Docket No. FDA-2023-N-2177, Medical Devices: Laboratory Developed Tests

    Dear Dr. Califf,

    On behalf of the 89 undersigned organizations representing patient advocacy organizations, medical and professional societies, hospitals, health systems, clinical laboratories, and more, we respectfully request an extension to the deadline to submit comments to Rulemaking Docket No. FDA-2023-N-2177, Medical Devices: Laboratory Developed Tests. Specifically, we ask that the December 4th deadline be extended an additional 60 days to provide adequate time for stakeholders to assess the impact of the proposed rule on patient access to care, clinical practice, and innovation.

    If finalized, the proposed rule would be a dramatic shift in how laboratory developed tests (LDTs) are regulated in the United States. This would not only potentially disrupt the current access patients have to clinical testing as laboratories narrow their test offerings or close due to the financial burden the rule places on them, but given the new premarket review requirements, the proposed rule could delay or prevent modifications and introductions of new tests that best reflect the latest scientific understanding and clinical practice guidelines.

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