Devices & Diagnostics

Medical device industry to FDA: No user fee hikes until goals met

The medical device industry is asking the FDA to take a couple more years to meet goals it says the watchdog agency has failed to meet before it agrees on reauthorizing user fees for another go-around. In the Medical Device User Fee Reauthorization or MDUFMA III negotiation meeting, which was held early in June, a […]

The medical device industry is asking the FDA to take a couple more years to meet goals it says the watchdog agency has failed to meet before it agrees on reauthorizing user fees for another go-around.

In the Medical Device User Fee Reauthorization or MDUFMA III negotiation meeting, which was held early in June, a group representing the medical device industry said the agency has “not yet achieved” some of the qualitative and quantitative goals set when the user fee program was reauthorized in 2007.

The minutes of the negotiation meeting, which included representatives from FDA, CDRH, as well as AdvaMed, MDMA and MITA were released yesterday on the FDA web site.

Industry’s well-documented gripes included increased review times for medical devices across the board and inconsistent spending of user fee collections.

“Industry characterized FDA’s performance by asserting a lack of focused and consistent training on core competencies and training to enhance scientific expertise, a lack of analysis of training effectiveness, and not holding vendor days in 2010 and holding limited reviewer site visits,” according to minutes of the meeting.

In addition, industry reps said that while it supported the goals and objectives of the user fee program, the current climate was not conducive to a new agreement on the user fee program and offered a compromise of extending the current program.

“Industry expressed concerns about developing meaningful goals and agreeing to associated resources for a five year program. Industry noted its intent was not to abort the program, but rather, to wait for FDA to resolve these policy issues and to allow FDA additional time to achieve MDUFA II commitments.”

Under the proposed compromise, industry would continue to pay user fees at current levels, allowing for a 4 percent inflationary increase each year.

“FDA asked if Industry considered the funding shortfalls this would create for the program, given that this would represent a decrease in MDUFA user fee spending. Industry acknowledged that there would be a decrease in MDUFA user fee spending,” according to the meeting notes.

FDA negotiators said they needed more time to consider the proposal and tabled its presentation of a commitment letter for the five-year reauthorization plan until a later meeting.

The current user fee act is set to expire in 2012. The agency first won the authority to collect user fees under the 2002 Medical Device User Fee and Modernization Act. The program was reauthorized in 2007 under MDUFMA II. The user fees were supposed to make up for the FDA’s resource shortfall to help it review device applications more quickly and, ultimately, speed devices to market. In return for receiving industry funding, the FDA was tasked with meeting performance goals under MDUFMA, which set benchmarks for measuring improvements in the agency’s review times.

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

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