FDA and Industry Reach Agreement in Principle on Medical Device User Fees

February 1, 2012—The US Food and Drug Administration (FDA) announced that the agency and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The industry associations that have reached the agreement with the FDA include the Advanced Medical Technology Association (AdvaMed), the Medical Device Manufacturers Association, and the Medical Imaging and Technology Alliance.

The recommendations would 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,the FDA stated.

According to the FDA, under a user fee program, industry agrees to pay fees to help fund a portion of the FDA's device review activities while the FDA agrees to overall performance goals such as reviewing a certain percentage of applications within a particular time frame.

The FDA advised that when the final details of the agreement with industry are completed, the agency will develop a package of proposed recommendations and give the public an opportunity to comment before they are submitted to Congress. The date of the public meeting has yet to be determined.

AdvaMed noted that in addition to reducing the total review time on a premarket approval (PMA) application or a 510(k) submission, the performance goals in the agreement would:

• Achieve significant performance improvements for PMA and 510(k) applications relative to current performance;

• Leave “no submission behind” by requiring the FDA to meet with companies if a performance goal on a PMA or 510(k) is missed and work out a plan for completing work on the submission; 


• Provide a substantive interaction with applicants halfway through the targeted time for completion of review, thus ensuring that a company can have time to properly respond to appropriate questions; and

• Implement an analysis of the FDA's management of the review process by an independent consulting organization, coupled with an FDA corrective action plan to address opportunities for improvement.