The Ins and Outs of the New FDA User Fee Bill

On October 1, FDA’s new medical device user fees will come into effect. The legislation will increase the amount device companies pay by 13% for a PMA (to $248,000) and 17% for a 510(k) (to $4,960). It will also enact a slew of other changes and new obligations enacted in the FDA Safety and Innovation Act.

The legislation has spawned a 20-page FDA document committing to detailed performance goals for the next five years. For instance, in 2013, the agency says it will issue a decision about whether or not to allow marketing for 91% of 510(k) submissions within 90 days.

And it commits the agency to a total time-to-decision limit for submissions received next year of 135 days, reducing to 130 days for FY 2015 and 124 days for FY 2017. The legislation also requires FDA to hire an outside consulting firm to evaluate its pre-market review process “and the agency’s progress in meeting these goals, including timely interactions with industry.”

While medical device industry sentiment has been increasingly critical of FDA’s regulatory drag on its economic condition, many companies openly hankering to shift R&D and new product launches to friendlier climes overseas, most of the big hitters seem on-board with the new law. They spent a lot of time wringing new performance commitments from the agency before they would sign on.

For its part, FDA welcomed the legislation’s passage, saying on its Web site that now it can collect $595 million (plus adjustments for inflation) in user fees over the next five years. “With the additional funding,” it said, FDA “will be able to hire more than 200 full-time-equivalent workers by the time the agreement expires in five years.”

The agency noted that the new law “will change the way the FDA approves clinical trials, provide a new de novo pathway for risk-based classification of devices, expand FDA's postmarket surveillance capabilities, shorten timelines for scheduling appeals meeting and issuing decisions, and change the process for reclassification of devices.”

Performance goals for FDA to meet are detailed and comprehensive, and accessible on its website.