After a year of negotiations, the U.S. Food and Drug Administration and representatives of the medical device industry have reached an agreement in principle regarding the medical device user fee program.
The two sides have agreed on proposed recommendations authorizing the FDA to collect $595 million in user fees — plus adjustments for inflation — over five years. Details of the agreement, such as the fee structure, are expected to be finalized soon, the FDA announced Wednesday.
It is the third reauthorization of a medical device user fee program, under which the industry agrees to pay fees to help fund a portion of the FDA's device review process. In return, the FDA agrees to overall performance goals such as reviewing a certain percentage of applications within a particular time frame.
According to the FDA, the agreement "strikes a careful balance between what industry agreed to pay and what the FDA can accomplish with the amount of funding proposed. It would result in greater accountability, predictability, and transparency through such improvements as a more structured pre-submission process and earlier interactions between FDA and applicants.
