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FDA user fee commitments drive diagnostics office priorities in 2008.

In vitro diagnostic issues promise to be an active area for FDA and device industry lobbyists this year in response to a laundry list of commitments agreed to by the agency as part of user fee reauthorization legislation.

The FDA Amendments Act, which includes the Medical Device User Fee Amendments (MDUFA), was signed into law Sept. 27, accompanied by commitment letters from FDA.

The device program letter is headlined by the new premarket review performance goals and FDA pledges to engage in "interactive review," but in vitro diagnostics are the individual product class that is most targeted with commitments.

FDA agreed to issue new or revised guidance for six explicit IVD topics. The agency also pledged to assess various reforms to the process of granting waivers to tests under the 1988 Clinical Laboratory Improvement Amendments so that the tests can be sold to a broader market of lower-tech clinic and physician office labs.

The agency further said it would review "low-risk" IVDs to consider whether they can be made exempt from 510(k) submissions as well as its pre-investigational device exemption meeting program for IVDs to see if it can be improved.

The MDUFA commitments "require some special attention to a wide variety of very important work items," affirmed Steve Gutman, director of the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD).

To help monitor OIVD's efforts on these matters, AdvaMed recently brought in a staffer, Khatereh Calleja, as the new associate VP for technology and regulatory affairs to focus exclusively on regulatory efforts in the diagnostics sector.

"We'll be spending a lot of time focusing on these implementation issues, working very closely with Dr. Gutman and his team over the new year," Calleja said. "This is an absolute priority for us."

The CLIA waiver commitments are among the most significant, leading with a pilot program to evaluate whether the 510(k)-review and CLIA-waiver review processes could be performed together.

Currently, waiver applications are not reviewed until after a firm has obtained 510(k) clearance. The waiver applications must include studies designed to prove that a test is sufficiently "simple" and error-proof to be performed by less sophisticated "waived" facilities that are exempt from CLIA inspections by CMS contractors.

During user fee reauthorization negotiations with FDA last year, AdvaMed pushed for parallel 510(k) and CLIA waiver review.

"We identified that the process should be done concurrently," said Janet Trunzo, executive VP of technology and regulatory affairs at AdvaMed. "There are similar elements in both, so why not make that an efficient process?"

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Title Annotation:Regulatory Report
Publication:Medical Design Technology
Date:Feb 1, 2008
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