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FDA Medical Device User Fees Bill Sails Through Senate Passage

NEW YORK (GenomeWeb News) – The US Senate yesterday overwhelmingly passed a bill that would reauthorize the Food and Drug Administration's medical device fees program for another five years and make changes aimed at streamlining the review and approval process.

Passed by a vote of 96 to 1 with 3 abstentions, the Food and Drug Administration Safety and Innovation Act (S. 3187) would extend the Medical Device User Fees Act, which is scheduled to expire at the end of September, through 2017. The legislation authorizes FDA to collect $595 million in user fees over five years, plus increases based on inflation, to help fund the agency's operations.

The user fees program was launched in 2002 to address concerns about the performance and capabilities of FDA's medical device review program, and it authorized the use of user fees for review of pre-market applications, reports, supplements, and pre-market notification submissions. That program was renewed in 2007 for a second five-year term.

This reauthorization also reflects concerns about FDA's performance in handling its medical device duties and represents an agreement between the agency and industry that was struck earlier this year, according to Jeffrey Shuren, who is director of FDA's Center for Devices and Radiological Health. Details of the agreement, such as the fee structure, are expected to be finalized soon.

Shuren explained in testimony before the Senate Committee on Health, Education, Labor and Pensions in March that the new program hinges on that agreement, which would use the new user fees to hire more than 200 full-time workers to support the medical devices review programs and to cut down the time it takes the agency to conduct reviews.

"We believe that it will result in greater predictability, consistency, and transparency through a number of improvements to the review process," Shuren told the committee.

The negotiations between FDA and industry lasted more than a year, and during that time FDA heard that "industry felt that inadequate predictability, consistency, and transparency were stifling innovation and driving jobs overseas," Shuren said.

Shuren told the committee that the recommendations in the new MDUFA will include enhancements to the review process, infrastructure, and capacity at CDRH and enhanced metrics for reviews. It also will implement more rigorous review performance goals and shared goal outcomes.

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