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Medical Device User Fee Agreement (MDUFA)

Medical Device User Fee

Under the “Medical Device User Fee and Modernization Act of 2002” (MDUFMA), FDA was given the authority to collect user fees from medical device sponsors for review activities. Under the legislation, FDA committed to meeting specific performance goals negotiated between industry and the agency related to medical device reviews.

The user fee program was reauthorized in 2007 as part of the “FDA Amendments Act of 2007” and again in 2012 as part of the “FDA Safety and Innovation Act.” The most recent user fee agreement negotiated between FDA and industry has the potential to be a game changer to improve the efficiency and predictability of the agency’s review process. The legislation includes a series of strong, measureable performance goals and additional resources that should help reverse the decline in performance FDA has experienced in recent years.

Medical Device User Fee ReAuthorization

On July 9, 2012, the President signed into law the “Food and Drug Administration Safety and Innovation Act” (FDASIA). The law implements an agreement negotiated between FDA and the medical technology industry to reauthorize the agency’s medical device user fee program.

Under the agreement, FDA has committed to meeting a number of strong and improved performance goals designed to increase the predictability and efficiency of the device review process. The performance commitments cover pre-submission process improvements, mandatory substantive interactions midpoint in the review process, improved FDA days goals, average total time to decision goals, an independent analysis of the management of the review process, and detailed quarterly reporting on performance, among others.

Separate from the user fee agreement, FDASIA includes several other provisions aimed at adding more consistency and efficiency to FDA’s device review program.

Below you will find a list of key materials on FDASIA for your convenience: