MDUFMA Receives Mixed Reviews from ManufacturersMDUFMA Receives Mixed Reviews from Manufacturers

Although medtech manufacturers generally agree with the purpose and objectives of the Medical Device User Fee and Modernization Act (MDUFMA), almost 70% of respondents to a recent study do not believe MDUFMA has resulted in meaningful improvements in the predictability and timeliness of device approvals. The study was commissioned by FDA and conducted by the Lewin Group (Falls Church, VA), a national healthcare consulting firm.

The study, Medical Device Industry Perspectives on MDUFMA: Final Report, was prepared by the Lewin Group in early February of this year, but was not released by FDA until late April.

Citing review times that are “about the same” as they were prior to MDUFMA and concerns about “continued unpredictable increases in user fees,” many manufacturers believe MDUFMA has not translated into a good return on investment (ROI). Many also believe that FDA may be using MDUFMA user fees to fund other agency activities.

According to the authors of the report, manufacturers widely dismiss the current data tracked and reported by the agency as not adequately measuring real program performance. As surveyed participants see it, “the total product review time is the measure most closely aligned with the understood purpose of MDUFMA and with ROI of industry user fees.”

Manufacturers also believe that communication between companies and FDA has suffered as a result of MDUFMA and that FDA reviewers are not as available for consultation as they were previously. The report finds that manufacturers believe reviewers now seem to “place higher priorities on deadlines than communication and artificially stop the clock on device review procedures in a effort to meet agency performance goals, which actually adds to the total review time.” About half of the survey respondents characterized the loss of quality communication with the agency as “contrary to the intent of MDUFMA.”

However, manufacturers do not hold FDA solely responsible for the problems incurred in the implementation of MDUFMA. Many view the agency as underresourced and believe that “the intent of MDUFMA remains undermined by insufficient appropriations from Congress.” They say that federal funding should be sufficient to cover the full cost of premarket reviews without resorting to user fees, which many see as a “double tax.”

Concerns were also expressed about FDA's review staff members, who were described by survey interviewees as “insufficient in number and limited in scope of relevant expertise and depth across product categories, particularly regarding use of new and emerging technologies.”

Although FDA continues to receive high marks from manufacturers for its role in ensuring device safety and efficacy, and is referred to as the premier worldwide regulatory authority for medical devices, MDUFMA is one agency program that doesn't generally share in the positive perception. The program continues to generate skepticism and controversy among manufacturers, as it has since its inception.

MDUFMA became law in 2002 and is scheduled to sunset in 2007. If it is to be reauthorized as MDUFMA 2, the Lewin report notes that manufacturers want to see changes focused on the following areas.

• Refining current review process cycle goals.

• Maximizing FDA staff effectiveness.

• Instilling greater transparency and predictability into the MDUFMA user fee structure.

• Placing greater emphasis on early feedback and establishment of clinical data requirements.

The Lewin report was initially available via the Web site of FDA's Center for Devices and Radiological Health at www.fda.gov/cdrh/mdufma/reports/lewin-020806.pdf. Shortly after its release, however, it was removed from the Web site and listed as “temporarily unavailable.” It had not been reposted at press time.

© 2006 Canon Communications LLC

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