Originally Published IVD Technology March 2005
INDUSTRY NEWS
FDA to issue new CLIA waiver guidance
Matt Grebow
FDA has said that this spring it will release a new draft guidance on how diagnostic products can obtain waived-complexity status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). At a Clinical Laboratory Improvement Advisory Committee meeting last September, FDA said the guidance would be ready by the end of 2004. In December, the release date was extended into 2005.
The guidance is expected to simplify the process and potentially ease the requirements for technologies to obtain so-called CLIA waivers. In the past, the criteria for such waivers were determined by the Centers for Medicare and Medicaid Services (CMS; Baltimore), in conjunction with FDA and the Centers for Disease Control and Prevention (CDC; Atlanta). “Although FDA was given the responsibility to review waiver requests, CDC and CMS had to concur with the final waiver decisions. This proved to be tedious and time consuming for FDA,” explains Tom Tsakeris, president of Devices and Diagnostics Consulting Group Inc. (Rockville, MD). “Complaints from the IVD industry as well as concerns expressed by FDA eventually resulted in more control for CLIA waivers being given to FDA.” This shift in power culminated last year when the agency assumed authority for making waived-status decisions, a move that was perceived to be friendlier to the IVD industry.
A key point of interest in the new guidance will be how FDA defines accuracy as it applies to diagnostic products. CDC and CMS have generally associated the term with a device’s technical specifications. By contrast, FDA has previously suggested (in a 2001 draft guidance that was withdrawn after only a few months) that accuracy is a comparative measure, and that a device should perform similarly in the hands of a lab professional and an untrained user. FDA’s definition drew fire from the IVD community, which found it too restrictive and out of step with how testing is conducted by physicians. Since the withdrawal of FDA’s earlier guidance, however, there have been complaints that the current waiver criteria developed by CDC and CMS have also proven to be regressive.
Over the years, CLIA has resulted in significant structural changes in the clinical laboratory marketplace. “The resulting regulations and requirements for paperwork, registration, and inspection put small physician office laboratories out of the testing business,” says Glen Freiberg, vice president of regulatory, quality, and government affairs at Gen-Probe Inc. (San Diego). With the shift of waiver authority to FDA, Freiberg believes that such determinations will likely be made as part of the 510(k) evaluation process, and that physicians will have better access to rapid tests.
FDA’s latest guidance could bring about more market changes, this time opening doors for some IVD manufacturers. “The opportunity will be for smaller manufacturers that can contract with a sales force that targets physician offices, or for other manufacturers that can find a way to cost-effectively deliver low-volume tests,” says Freiberg, who adds, “Where an instrument is involved, superior reliability will be the key to any opportunity for profit on such testing.”
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