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User Fee Deal Clears Next Step

The OMB gives the pact its OK.

By: Chris Delporte

Editor

The White House has signed off on the user fee agreement between the U.S. Food and Drug Administration (FDA) and the medical device industry, bringing MDUFMA III—the latest iteration of the Medical Device User Fee and Modernization Act—a step closer to reality.

The Office of Management and Budget’s thumbs up comes one month after the industry and FDA worked out an agreement that calls for device makers to double the fees they pay FDA—from $295 million over five years to $595 million—in exchange for performance goals including faster and more predictable reviews.

The next step in the process is public meeting on March 28 in which interested parties will be allowed to provide feedback on the draft recommendations. The public workshop will be held at 9:00 a.m. at the Hubert H. Humphrey Building, headquarters of the U.S. Department of Health and Human Services, in Washington, D.C.

“We welcome this opportunity to hear from stakeholders as we conclude negotiations for the next reauthorization of the medical device user fee program,” said FDA in its meeting announcement.

The FDA will publish the agreement in the Federal Register for a 30-day public comment period and make final revisions before presenting the package to Congress for full legislative review. The current user fee program expires in September.

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