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MDUFA V Agreement Reached

March 24, 2022

The FDA and representatives from the medical device industry have reached an agreement on proposed recommendations for MDUFA V. On March 22, FDA sent the commitment letter to Congress.

Under the new agreement, the FDA would be authorized to collect at least $1.78 billion in user fees over five years. FDA could receive additional funding up to a total of $1.9 billion if specified goals are met. The MDUFA V proposed recommendations will be published in the Federal Register for public comment. FDA will also hold a virtual public meeting on April 19.

The deal also includes a pilot program of the FDA’s total product lifecycle advisory program or (TAP) that had been a big sticking point during negotiations. TAP will be funded from a combination of new money and $110 million of the $209 billion carryover balance from MDUFA IV. TAP is intended to bring in outside stakeholders such as physician advisors and insurers to help device sponsors during product development. The pilot includes a mid-point evaluation so FDA and the industry can see if the program is working.

After receiving public input, final recommendations will be delivered to Congress next month, setting the stage for key health committees to consider legislation to reauthorize the user fee program along with any potential policy riders. Congress must act on the user fee reauthorization by the end of September.

View FDA Statement HERE

View MDMA Statement HERE

View AdvaMed Statement HERE

View MITA Statement HERE