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    The undersigned laboratory groups sent a letter to the Director of the FDA's Center for Devices and Radiological Health requesting interactive meetings to discuss the FDA's proposed regulation of laboratory developed tests (LDTs) before moving forward with any proposals. They note that LDTs provide value to patient care and represent areas for medical advancement. They ask that the FDA consider the operational differences between LDTs and medical device test kits, as well as the resources needed to oversee the large number of similar LDTs. The groups offer to work with the FDA to provide insights into test development and quality assurance processes for LDTs.

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    The undersigned laboratory groups sent a letter to the Director of the FDA's Center for Devices and Radiological Health requesting interactive meetings to discuss the FDA's proposed regulation of laboratory developed tests (LDTs) before moving forward with any proposals. They note that LDTs provide value to patient care and represent areas for medical advancement. They ask that the FDA consider the operational differences between LDTs and medical device test kits, as well as the resources needed to oversee the large number of similar LDTs. The groups offer to work with the FDA to provide insights into test development and quality assurance processes for LDTs.

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    FDA-2010-N-0274-0109.1

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    The undersigned laboratory groups sent a letter to the Director of the FDA's Center for Devices and Radiological Health requesting interactive meetings to discuss the FDA's proposed regulation of laboratory developed tests (LDTs) before moving forward with any proposals. They note that LDTs provide value to patient care and represent areas for medical advancement. They ask that the FDA consider the operational differences between LDTs and medical device test kits, as well as the resources needed to oversee the large number of similar LDTs. The groups offer to work with the FDA to provide insights into test development and quality assurance processes for LDTs.

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    26 views2 pages

    TH TH

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    fdablog
    The undersigned laboratory groups sent a letter to the Director of the FDA's Center for Devices and Radiological Health requesting interactive meetings to discuss the FDA's proposed regulation of laboratory developed tests (LDTs) before moving forward with any proposals. They note that LDTs provide value to patient care and represent areas for medical advancement. They ask that the FDA consider the operational differences between LDTs and medical device test kits, as well as the resources needed to oversee the large number of similar LDTs. The groups offer to work with the FDA to provide insights into test development and quality assurance processes for LDTs.

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    of 2

    September 15, 2010

    Jeffery E. Shuren, M.D., J.D.


    Director, Center for Devices and Radiological Health
    U.S. Food and Drug Administration
    Building WO66, Room 5442
    10903 New Hampshire Ave.
    Silver Spring MD 20993

    ˜  
         

    Dear Dr. Shuren:

    The undersigned groups, which represent the full spectrum of laboratory medicine
    operations and the providers of clinical and public health laboratory tests, are united in the
    desire to engage with U.S. Food and Drug Administration (FDA) in an interactive dialogue
    to explore and seek solutions that will not disrupt innovation and the value laboratory
    developed tests (LDTs) bring to patient care. As overwhelmingly communicated at the July
    19th and 20th public meeting, LDTs are a value-added service to patient care. They are
    created to respond to patient care and public health needs and many LDTs represent the
    most fertile area for medical advancement.

    The clinical laboratory community appreciated the public meeting as an opportunity to


    provide input on the regulation of LDTs. To keep the process moving forward, we ask that
    FDA host inter-active meetings with laboratory stakeholders to discuss specific issues
    about the framework for FDA regulation before FDA moves forward any proposal in this
    area.

    LDT oversight is a complex new initiative for the agency. The potential additional
    resources necessary to assume this regulatory function cannot be underestimated.
    Currently FDA approves a single application for a test kit which can then be utilized by
    numerous laboratories. In question is how FDA will approach the regulation of multiple
    similar, if not the same, laboratory developed tests submitted by many clinical laboratories.
    The case for these additional resources needed to review many new (and similar)
    applications needs to be clearly defined and balanced, especially because oversight is
    already in place by federal, state and accreditation authorities.

    Lacking clearly defined boundaries, the regulation of LDTs presents challenges in both the
    scope they represent as well as in the intrinsic complexity associated with the way they are
    performed in the clinical laboratory. For example, the development of multiple array,
    probe and marker testing presents challenges for the submission of a single intended use
    claim required for FDA clearance. Because of the complexity, regulatory requirements
    must be clear, consistent and responsive to the rapid pace of innovation.

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    Clinical laboratories are not á ádiagnostic test kit (IVD) manufacturers, and the
    differences between the two entities have never been adequately addressed, not only with
    regard to laboratory processes, but also physical facilities. LDTs are operationally different
    than medical device products. Medical device test kits are developed, packaged, labeled,
    sold and shipped by manufacturers to clinical laboratories throughout the U.S for use by
    the laboratories in the practice of clinical laboratory medicine. On the other hand, none of
    these are true for LDTsȄwith LDTs, it is a single entity that develops and performs the test
    and furnishes results to treating providers.

    Given the significant change in policy and expansion of its regulatory oversight
    contemplated by FDA, with massive implications to patient care and professional
    standards, continued receptivity to stakeholder ideas and input is imperative before FDA
    moves forward any proposal in this area. FDA will benefit from insights on how tests are
    developed, validated and quality ensured and the laboratory community will benefit from
    hearing from FDA how medical device regulation can be flexibly applied to LDTs. When
    FDA eventually does move ahead with a proposal, it should be done through an interactive,
    transparent, and accountable process such as is the case with formal rulemaking.

    A representative of the groups listed below will be in contact with you to work toward this
    important dialogue.

    Sincerely yours,

    American Association for Clinical Chemistry


    American Clinical Laboratory Association
    American College of Medical Genetics
    American Medical Technologists
    Association for Molecular Pathology
    American Pathology Foundation
    American Society for Clinical Laboratory Science
    American Society for Clinical Pathology
    American Society for Microbiology
    Association of Public Health Laboratories
    Clinical Laboratory Management Association
    Coalition for 21st Century Medicine
    College of American Pathologists

    Cc: Margaret A. Hamburg, M.D., Commissioner U.S. Food and Drug Administration

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