FDA: Reps Paulsen, Eshoo call for quarterly reports on MDUFMA progress

Friday, October 12, 2012  by MassDevice staff

Rep. Erik Paulsen tells MassDevice.com that congress wants higher user fees to come with greater accountability.

Some members of congress are calling for the FDA to provide quarterly reports on the agency’s progress toward meeting the goals set forth in the recent medical device user fee agreement.

Reps Erik Paulsen (R-Minn.) and Anna Eshoo (D-Calif.) sent a letter to the federal watchdog agency in late August asking the FDA to provide Congress with quarterly reports on whether or not they’re meeting specific goals and milestones set forth in the recently passed re-authorization of Medical Device User Fee & Modernization Act, Paulsen told MassDevice.com this week.

Paulsen told us the goal of the request is to continue to hold the FDA’s feet to the fire.

“We thought it was important that, given all the work we did with the re-authorization work, that we should have some follow up,” he said.

The Minnesota lawmaker said he hasn’t received a formal response from the FDA but is intent on following up with the agency to make sure they’re in compliance. Specifically, Paulsen wants the agency to inform legislators if they’re going to miss any of the benchmarks set forth in the agreement.

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