FDA, Medical Device Industry Come to Terms

After more than a year of negotiations, the US Food and Drug Administration and the medical device industry arrived at an "agreement in principle" on proposed recommendations for the third reauthorization of a medical device user fee program, according to an FDA release.

The recommendations authorize the FDA to collect $595 million in user fees over 5 years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.

“I want to commend my staff and representatives from industry for their tireless work and commitment to achieving an agreement in principle on medical device user fees,” said FDA Commissioner Margaret A. Hamburg, MD. “Reauthorization of this important program is an essential component for advancing medical device innovation.”

The industry associations that have reached an agreement in principle with the FDA include the Advanced Medical Technology Association, the Medical Device Manufacturers Association, and the Medical Imaging and Technology Alliance.

Detailed information on meetings on the Medical Device User Fee Act (MDUFA) program is available from the FDA.