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

FDA and representatives from the medical device industry reached an agreement in principle on proposed recommendations for the 3rd reauthorization of a Medical Device User Fee program. Recommendations would authorize FDA to collect $595 million in user fees over 5 years, plus adjustments for inflation. Additional funding will support the addition of >200 full-time equivalent staff by the end of the 5-year program to reduce average total review times.

FDA and industry expect that the agreement in principle would result in a reduction in average total review times.

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.

Once final details of the agreement with industry are completed, FDA will develop a package of proposed recommendations open to public commentary before they are submitted to Congress. The date of the public meeting has yet to be determined.

REFERENCE

FDA and industry reach agreement in principle on medical device user fees, FDA.gov, February 1, 2012.

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