MDUFMA Reauthorization Agreement Is In Place - AdvaMed

From the March 5, 2007, issue of "The Gray Sheet"

The medical device industry has reached an agreement with FDA on what will be included in updated user fee legislation, according to AdvaMed President Steve Ubl.

The pact "accomplishes three important things," Ubl said at a Feb. 27 press briefing. "We have made significant improvements in [FDA's] performance [goals], we will significantly reduce application fees and we will change the mechanism such that the year-over-year increases in fees will be much more predictable than they were in the first go-around."

A CDRH spokesperson said March 1 that the agency is "fine-tuning the details" of the legislative recommendations. "We expect to complete this effort within the next few weeks," the agency rep said.

FDA will publish its recommendations in the Federal Register and hold a public stakeholder's meeting about 30 days later.

For more than a year, industry stakeholders and FDA have been in closed-door meetings hashing out user fees and review timetables that the agency will propose in recommendations to Congress for the reauthorization of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), which sunsets Sept. 30, 2007.

The 2002 law established medical device industry user fees, but also triggered FDA premarket submission performance goals, instructing the agency to follow specified timelines for both final PMA and 510(k) decisions and for interim actions like major deficiency letters.

Industry, also represented by the Medical Device Manufacturers Association and the National Electrical Manufacturers Association, complained during much of the early years of MDUFMA about the unpredictability of annual user fees increases. Device firms have also said MDUFMA II should improve the predictability of premarket review by emphasizing the overall time from submission to final FDA decision rather than on interim activities.

Stakeholders other than AdvaMed were not ready to publicly announce a final agreement, though they say the negotiations are nearing completion.

- Katherine Thomas, Pamela Taulbee

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