The U.S. Food and Drug Administration (FDA) today proposed recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA II), which, if adopted, would help to ensure that safe and effective medical devices get to patients in a timely manner. FDA is accepting public comments on the proposal for the next 30 days and is holding a public meeting on April 30.

Under the medical device user fee program, industry covers a portion of the costs of FDA's pre-market review program through a variety of fees. The fees are used in concert with the agency's annual appropriations to help FDA meet its review performance goals, which would speed more promising products to market than before. The industry user fees represent less than a quarter of the overall device budget for MDUFMA II.

"The proposal would give companies predictable fees and improved review times as well as provide FDA with a steady source of additional funding for its device review program," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "We look forward to working with Congress on this proposal."
The following are the key components of the proposal.
Fee Structure

MDUFMA II would provide industry with predictable and more stable fees because the amount for each type of fee for each year of the program would be prescribed in the statute.

Manufacturers would continue to pay fees when they submit applications for some types of medical device applications, but at a lower rate than under the current program. The proposal would also provide for additional fees. A fee would be assessed on facilities that register with FDA as a medical device manufacturer. In addition, annual report filing fees would be collected for pre-market approvals.
Performance Goals

The additional revenues generated from fees paid by the medical device industry would continue to be used to ensure patients have timely access to safe and effective medical devices. For example, FDA would reach a decision on 50 percent of expedited pre-market applications and expedited supplement applications that go before an FDA advisory committee within 180 days; 90 percent within 280 days. FDA would reach a decision on 60 percent of conventional pre-market applications and supplement applications that go before an FDA advisory committee within 180 days; 90 percent within 295 days. In addition, FDA would reach a decision on 90 percent of 510(k) applications (lower-risk devices) within 90 days; 98 percent within 150 days.

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