May 30, 2001

Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Dear Sir/Madam:

The American Association for Clinical Chemistry (AACC) welcomes the opportunity to comment on the Food and Drug Administration's (FDA's) "Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA," which outlines the agency's alternative criteria for waiving tests under the laboratory standards. We support FDA's effort to clarify the regulatory language, ensuring that the criteria are consistent with recent statutory changes.

In recent years, technological advances have allowed manufacturers to develop new and simpler devices, which make it easier for individuals with less training to accurately perform tests that were previously performed in more sophisticated laboratories. This technology-based trend is likely to accelerate in the near future. There are great benefits to simple, waived tests, such as the potential for diagnosing and treating the patient earlier and reducing overall health care costs.

However, as we move forward in this dynamic and fast growing area, it is important to remember that no device is "foolproof" and that errors can occur. Therefore, it is imperative that the FDA, Health Care Financing Administration (HCFA) and Centers for Disease Control and Prevention (CDC)-the federal agencies responsible for administering CLIA'88-remain vigilant in fulfilling their duties by ensuring that laboratories using these devices are complying with existing federal requirements.

We are particularly concerned by recent findings of the Health Care Financing Administration (HCFA) and its state survey agencies, which indicate that a significant percentage of waiver (and provider performed microscopy) laboratories are not following the manufacturer's instructions-the only substantive requirement they are subject to under CLIA'88-when performing a test. AACC is concerned that these problems could lead to inappropriate patient care. Since CLIA'88 is a jointly administered program, we urge the FDA to coordinate its CLIA activities with the other federal agencies and that you establish means for ensuring appropriate and effective federal oversight of all laboratory testing, including waiver tests. Our specific comments follow:

General Comments
AACC applauds FDA's efforts to provide manufacturers with guidance on what information needs to be submitted for a device to be considered for waived status. Although the current document is a good start, we believe it can be improved by providing manufacturers with clearer, more precise instruction. Too often, the agency uses such words as "should" or "may," which infers that a recommendation is optional, when it appears that the intent of the agency is to require specific action. For example, the agency states that manufacturers "should" provide clear and plain instructions, "should" include specific information on how to use and interpret a test and "may" choose to include good laboratory practice information in the package insert. If the agency believes this information is essential for the end user, then it must use words such "will" or "must," which will eliminate possible confusion and future disputes.

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