IVD Technology
Magazine
IVDT Article Index
Originally published September, 1998
Editor's Page
Pass the torch, please
FDA officials aren't saying much about it, but another move is apparently under way to have the agency take back responsibility for categorizing the complexity of IVD tests—a task originally assigned to it under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
The idea certainly has the support of industry. As early as 1990, when the CLIA regulations were being written, the Health Industry Manufacturers Association advocated the view that FDA should integrate the categorization activities required by CLIA with its usual premarket product reviews. But as any CLIA-watcher knows, even well-supported ideas are sometimes difficult to bring into being.
According to the CLIA regulation, responsibility for complexity categorization has always belonged to FDA. In practice, however, the agency has never performed this duty. Instead, hampered by a lack of funding and staff resources, the agency entered into a working agreement that effectively turned over the job of categorization to the Centers for Disease Control and Prevention (CDC), where it has resided since 1994. Under the current system, a manufacturer seeking to bring an IVD to market must first have it cleared or approved by FDA, and then have it categorized by CDC according to the three levels of complexity stipulated by CLIA.
Industry has not been alone in noticing that such a two-tiered system is both inefficient and time consuming. Characterizing the system as a wasteful and duplicative review process, a July 1997 report of the Senate Labor and Human Resources Committee urged FDA to "reassert its exclusive role in the implementation of the complexity evaluations under the CLIA regulations." It was just such pressure from Congress that apparently led FDA and CDC to open discussions on the possibility of returning the categorization function to the agency.
Although industry sources say that these discussions have been going on behind closed doors for about six months, it is unclear what results they have produced. Susan Alpert, director of the Office of Device Evaluation at FDA's Center for Devices and Radiological Health, confirmed that "the issues are under discussion by senior-level personnel at both FDA and CDC," but would not comment on specifics.
Meanwhile, manufacturers have also been busy considering the transfer of CLIA responsibilities from CDC to FDA. In August, an early draft of a think-paper on the subject was being circulated among IVD manufacturers for comment. The draft outlined a number of issues to be considered in connection with such a transfer, including the scope of responsibilities to be transferred (notably including policy development and the review of quality control instructions), methods to coordinate the transfer, and improvements to the CLIA review process that might be carried out as part of the transfer (including integration of premarket review and complexity categorization, the development of guidance documents, and the use of rule making to bring the process into conformity with the requirements of the FDA Modernization Act of 1997). Sources indicate that the draft is expected to be circulated among clinical laboratory organizations for further input before being presented to a joint meeting involving FDA, CDC, and the Health Care Financing Administration.
For all their efforts, however, neither manufacturers nor laboratorians have so far been directly involved in the discussions between FDA and CDC, which have remained a somewhat secretive affair. That's not good policy. Considering the complexity of the issues involved in CLIA, and the many companies and laboratories that will be affected by any transfer of CLIA responsibilities, it would be better if the current discussions were carried out openly. Shedding a little light on the subject now might save a lot of interested parties from having dark days in the future.
Steven Halasey
