Originally Published IVD Technology April 2001
Industry News
Waived-complexity guidance enters comment period
When it comes to the simplest of IVD tests, it
seems, nothing is simple.
FDA has recently issued a draft guidance on its proposed criteria for assigning waived-complexity status to IVDs under the terms of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). But, the agency advises, don't look for a final rule on the subject anytime soon.
The draft document, entitled Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA, was formally released for public comment on March 1 of this year. The 90-day comment period is scheduled to close on May 30.
The agency expects to repropose the regulation to clarify waiver criteria; however, "it will be some time before a final rule is codified." In the meantime, the draft guidance is likely to become the de facto regulation for CLIA waiver applications. Release of the new guidance represents the latest in a long series of events that have added nothing but complexity to the process of complexity categorization.
CLIA originally gave FDA responsibility for assigning IVDs into the high-, moderate-, or waived-complexity categories established by the amendments. Pleading a lack of resources, however, in 1994 the agency entered into an agreement for the Centers for Disease Control and Prevention (CDC) to perform this duty.
In 1995, CDC and the Health Care Financing Administration (HCFA) issued a notice of proposed rule making that would have established criteria for granting a CLIA waiver to tests. Under that rule, CDC expected to grant waived-complexity status only after conducting an examination of the clinical characteristics of a test (for example, its specificity and sensitivity).
A dozen years after passage of CLIA, complexity categorization activities finally returned to FDA in January 2001—but only after months of negotiations to ensure a smooth transition of resources. Since then, the division of clinical laboratory devices in FDA's Office of Device Evaluation has performed complexity categorization in conjunction with its regular premarket review of commercial IVD products submitted to the agency. Until now, the agency has been using the criteria specified in the 1995 proposed rule as the basis for its decisions.
With the release of its draft guidance, however, the agency seems intent on making up for lost time. And IVD manufacturers, who have long argued that the 1995 proposed rule was duplicative and unnecessarily restrictive, have some reason to be thankful that FDA is taking charge of complexity categorization.
While not displacing the criteria established by the 1995 proposed rule, the draft guidance is intended to provide "another mechanism you can use to obtain CLIA waiver using valid scientific evidence." Under the terms of the draft guidance, FDA would require manufacturers to demonstrate that their products are simple and pose an insignificant risk of erroneous results. In addition, the guidance calls for manufacturers to conduct a series of agreement studies aimed at demonstrating that the test in question will provide the same accuracy whether it is administered by a layperson or a trained professional.
Manufacturers expect that use of the new criteria will make it easier for some tests to achieve waived status, and perhaps increase the number of such tests available in the marketplace.
Not everyone, however, is happy about such a possibility. Members of the laboratory community have expressed concern that the new guidance could take many tests out of the hands of experienced professionals and allow them to be used by untrained lay users or less-experienced laboratory technicians. Citing the possibility that such users may not follow manufacturers' instructions for use, some laboratorians have suggested that waived tests should be subject to additional controls, such as documentation of users' ability to perform a test, random inspections of waived-complexity laboratories, or a mandatory quality control program.
Information from HCFA has suggested that a chronic absence of routine quality control for waived tests could indeed be a problem. Last fall, HCFA inspectors noted a finding that waived-complexity laboratories were not following manufacturers' quality control instructions as required.
Partly in response to this finding, the Clinical Laboratory Improvement Advisory Committee (CLIAC) recommended in February that FDA mandate the use of labeling that would require labs to perform necessary quality control procedures.
At press time, members of the IVD Task Force at AdvaMed (Washington, DC) were said to be reviewing the draft guidance with the intent of submitting formal comments. Initial concerns expressed by task force members include the volume of data required to demonstrate that laypersons can perform the test with the same success as professionals, and the bases for selecting the data set for such demonstrations. Representatives of professional associations were also expected to provide comments on the draft.
Copies of the draft guidance are available on-line via the CDRH Web site at http://www.fda.gov/cdrh/ode/guidance/1147.pdf.
—Steve Halasey
Copyright ©2001 IVD Technology
