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    December 4, 2023 

    The Honorable Robert M. Califf, MD
    The U.S. Food and Drug Administration
    5630 Fishers Lane, Rm. 1061
    Rockville, MD 20852

    Re: Medical Devices; Laboratory Developed Tests (FDA– 2023–N–2177)

    Dear Commissioner Califf:

    The Medical Group Management Association (MGMA) is pleased to submit the following comments in response to the Food and Drug Administration’s (FDA) Medical Devices; Laboratory Developed Tests proposed rule, published in the Federal Register on Oct. 3, 2023.

    With a membership of more than 60,000 medical practice administrators, executives, and leaders, MGMA represents more than 15,000 medical groups comprising more than 350,000 physicians. These groups range from small independent practices in remote and other underserved areas, to large regional and national health systems that cover the full spectrum of physician specialties.

    For years, MGMA has advocated for a robust clinical laboratory infrastructure to support the delivery of routine patient care. Medical groups rely on Laboratory Developed Tests (LDTs) to provide essential diagnostic and testing services to patients. As such, MGMA is well-positioned to offer the following feedback.

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