The agreement in principle is the result of over a year of negotiations between the FDA and industry. It 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. With the additional funding, the FDA would be able to hire over 200 full-time equivalent workers by the end of the five-year program. The FDA and industry expect that the agreement in principle would result in a reduction in average total review times.
Press Announcements - FDA and industry reach agreement in principle on medical device user fees:
"FDA and industry reach agreement in principle on medical device user fees
The FDA 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 recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.
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."
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