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FDA to offer one-stop regulatory shopping
The transition has been years in the making, but on January 31, 2000, FDA will finally begin making complexity categorization determinations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
The agency's Division of Clinical Laboratory Devices (DCLD) will take over this function from the Centers for Disease Control and Prevention (CDC), which has been performing the duty since 1992. CDC ended up with the duty when FDA indicated that it did not have the resources to accomplish the task assigned to it in the CLIA legislation.
"CLIA categorization by FDA will allow manufacturers to submit applications for product clearance and requests for complexity categorization at the same time, to the same agency—one-stop shopping," says Clara Sliva, acting CLIA coordinator and assistant to the DCLD director. "The same reviewer will clear and categorize the test system."
Speaking in October at the Association of Medical Diagnostic Manufacturers annual meeting, in Rockville, MD, Sliva said that she anticipates a guidance document for IVD manufacturers regarding CLIA complexity determinations to be available in late November 1999.
In preparation for the shift in responsibilities, Sliva and Joseph Hackett, PhD, associate director clinical laboratory devices at DCLD, are heading up a transfer team. The team has been working side-by-side with CDC personnel during the training period and, beginning in November, will take the lead in making complexity determinations. "We will still be making the decisions jointly, but FDA will be leading the team at that point," says Hackett.
The next steps in the transition include transferring CDC's database to DCLD and completing the transfer team training. "The last thing to be up and running will be the waiver process," said Hackett. "This is the most difficult."
Sliva said that she expects a guidance for IVD manufacturers requesting waived complexity status to be available in late December 1999.
FDA's team is expected to continue meeting with CDC on a weekly basis through April 2000 to ensure a smooth transition. "I think we're prepared to start making complexity determinations," says Sliva. "It will be a great benefit to manufacturers."—Susan Wallace
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