The Honorable Donna Shalala
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Secretary Shalala:

The Food and Drug Administration (FDA), as the agency responsible for categorizing laboratory tests under CLIA'88, is currently streamlining the process for making such decisions. We share the agency's desire to make this process more efficient and consistent and applaud their efforts to include outside organizations in the development of this policy. However, we are concerned that the FDA may soon make a decision regarding how it categorizes waived tests without the advice of the federal advisory panel-the Clinical Laboratory Improvement Advisory Committee (CLIAC)-empowered to assist them.

At the recent September 27-28 CLIAC meeting, the FDA mentioned that it was considering changing the definition of "accuracy" for evaluating whether a test should be placed in the waiver category-a category subject to little federal oversight even though more than 50 percent of all laboratories perform only such testing. CLIAC has written to you requesting that it have the opportunity to review this and other potential changes and offer its suggestions to the agency. Given the potential impact any changes may have on the types and number of devices placed in this category, we believe it is a reasonable request.

Therefore, AACC urges you to support CLIAC's request and give them the opportunity to provide input to the FDA before it finalizes its changes to the criteria for categorizing waived tests. We further support their request that the current requirements remain in place until this decision is made, so that manufacturers with applications currently before the agency are not unfairly penalized.

By way of background, AACC is the principal association of professional laboratory scientists--including MDs, PhDs and medical technologists. AACC's members develop and use chemical concepts, procedures, techniques and instrumentation in health-related investigations and work in hospitals, independent laboratories and the diagnostics industry nationwide. The AACC's objectives are to further the public interest and educational activities and to help maintain high professional standards.

If you have any questions or we may be of any assistance, please call me at (919) 684-8724 or Vince Stine, Director, Government Affairs, at (202) 835-8721.



Frank A. Sedor, PhD

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