Originally Published IVD Technology
September 2003
INDUSTRY NEWS
Analytical tests may receive a new route for reviewA nalytical tests may soon reach the market faster. A review mechanism that would provide an alternative to the 510(k) route for innovative analytical tests has been proposed in a draft guidance submitted to FDA by representatives from
Gen-Probe Inc. (San Diego), Becton Dickinson (Franklin Lakes, NJ), and
Roche Diagnostics (Basel, Switzerland).
The new mechanism would provide a premarket notification pathway in which FDA would focus on analytical validity in lieu of clinical validity when reviewing in vitro analytical test (IVAT) kits. The analytical 510(k) would be subject to user fees and FDA would have to generate a premarket notification decision, based upon a determination of substantial equivalence within 60 days of submission.
The draft guidance describes IVATs as “generic types of devices that are intended for use as in vitro diagnostic tests for the qualitative or quantitative measure of an analyte.” It further defines analytical validity as “the ability of a test to measure the property or characteristic that it was designed to measure by calculating such values as analytical specificity and sensitivity.”
One of the principal motivators behind the proposal was the expedited review time. “We believe that most of the review time is spent on an assessment of the clinical data. If such an assessment is not necessary, there is no reason to take three months,” says Glen Freiberg, vice president for regulatory, quality, and government affairs at Gen-Probe. “In addition, the submission to FDA would come much earlier, as the time needed to conduct the clinical trial would be eliminated.”
Kits approved through the analytical 510(k) route would be subject to the same labeling restrictions and postmarket controls as those prescribed by the traditional 510(k). However, IVAT 510(k) submissions would not specify a clinical application for the test or use the established normal range for the analyte being examined.
Analytical requirements for FDA clearance would be based upon the manufacturer’s claims made in the product inserts. The normal range would be established by laboratories purchasing the IVAT.
“One of the prime drivers of lab home-brew activity is early adoption of new tests. If labs could receive new GMP-manufactured tests in kits with full instructions sooner, it could be advantageous to all parties,” says Freiberg.
The proposal’s authors invite commentary on whether information is being required for the IVAT 510(k) that does not seem relevant to FDA’s regulatory assessment of the product, or whether there may be a less burdensome way to address the issues involved in regulating these products.
FDA has agreed to discuss the proposal with its supporters from industry during the October 24 meeting of the IVD Round Table.
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