FDA, medical device makers reach deal on user fees

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The Food and Drug Administration and the medical device manufacturing industry have reached a tentative agreement on user fees under the reauthorization of the Medical Device User Fee Act.

Though all the details of the proposed recommendations for the reauthorization have not been finalized, the parties have agreed in principle to a system that would allow the FDA to collect $595 million in user fees over five years – roughly double what the government collected under the previous user fee program renewal. The new system will be implemented in September when the current program expires.

The user fee system authorizes the FDA to collect fees from medical device companies to fund a portion of the FDA’s device review and approval process. Under the program, the FDA agrees to overall performance goals such as reviewing a certain percentage of applications within a particular time frame. Medical device industry officials from the Advanced Medical Technology Association, the Medical Device Manufacturers Association and the Medical Imaging and Technology Alliance have been negotiating the terms of the latest fee renewal with federal officials for more than a year.

The fees collected under the fee renewal terms will give the FDA additional funding to hire over 200 full-time equivalent workers by the end of the five-year program, FDA officials said in a statement.

The negotiations between the parties took place as the FDA’s 510(k) process – the so-called “fast track” approval process for lower risk medical products – came under increased fire after critical medical journal reports and statements by public health advocates. These critiques led the FDA to announce that it would implement changes to its process of reviewing devices that are deemed low risk before they go to market.

The issue has been the subject of several hearings before the Senate Committee on Health, Education, Labor and Pensions.

The chairman of the committee, Sen. Tom Harkin, D-Iowa, praised the agreement.

“This user fee agreement will ensure that life-saving medical devices reach patients who need them quickly and safely [and] encourage innovation and ensure that the review process for new medical devices is consistent and transparent,” Harkin said in a statement.