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Spare change?
For anyone who thinks that change is easy—or fun—now would be an excellent time to venture into the business of manufacturing IVDs. For diagnostics companies, there are plenty of changes on the way.
For instance, we have previously reported on the negotiations between FDA and CDC over responsibility for categorizing the complexity of lab tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Last autumn industry sources were freely saying that the transfer of categorization responsibilities from CDC to FDA was all but a done deal, and a summit meeting that included representatives from FDA, CDC, and industry was held in early December to discuss details of the transfer. But since then, industry sources have been quiet about the deal.
A much more public set of changes is that proposed in December by the Negotiated Rulemaking Committee on Clinical Diagnostic Laboratory Tests. Under a mandate of the Balanced Budget Act of 1997, this committee is charged with developing a national policy for reimbursement coverage of diagnostic tests under Medicare. At its December meeting, the committee discussed a draft of the policies under consideration. That draft—and the minutes of all the committee's meetings—can be found on the HCFA Web site.
But the biggest changes on the way for IVD manufacturers are those that will be brought about by the European Union's long-awaited passage of the IVD Directive (see Maurizio Suppo's article beginning on page 18 of this issue). Manufacturers are justifiably nervous about what the directive will mean to them. There is uncertainty about the technical documentation that will be required, and confusion over whether like products might be grouped to minimize documentation requirements. Some companies worry that buyers could be misled about the need for CE marking during the directive's transition period, giving an unfair advantage to companies that achieve the CE mark before it is required. According to Glen Frieberg, senior director for regulatory affairs at Gen-Probe Inc. (San Diego), "for products where there are alternative vendors, early CE marking may be more important than pricing."
Considering how price-competitive the market in diagnostics has become, that's real change.
