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    May 22, 2022 

    The Honorable Patty Murray
    Chair, Senate Committee on
    Health, Education, Labor and Pensions
    154 Russell Senate Office Building
    Washington, DC 20510

    The Honorable Richard Burr
    Ranking Member, Senate Committee on
    Health, Education, Labor and Pensions 
    217 Russell Senate Office Building
    Washington, DC 20510

    Dear Chairwoman Murray and Ranking Member Burr,

    Thank you for the opportunity to provide this feedback on the discussion draft of the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act and in particular, Subtitle C of Title VIII which includes the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2022. The undersigned organizations represent a diverse and broad community of healthcare professionals, industry organizations, medical institutions, and pathology departments who practice laboratory medicine, provide clinical testing services, and deliver high quality care to patients throughout the US.

    We write to you today to express our significant concerns with the VALID Act of 2022 and request that you provide additional and sufficient time to resolve these concerns prior to advancing this legislation. We recognize that the user fee reauthorization offers a fast moving legislative vehicle; however, since this proposal dramatically modifies the current regulatory framework for an entire category of medical services, itโ€™s critical that this is done right to protect patient access to innovative diagnostics. As such, we respectfully request that you allow time for further refinement of the VALID Act and do not rush this very flawed, problematic legislation through the user fee reauthorization legislative process.


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