The U.S. Food and Drug Administration (FDA) and representatives of the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program after more than a year of negotiations.
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, the agency noted in a press release.
Once the final details of the agreement with industry are completed, the FDA 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.
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.
According to the FDA, the program would result in greater accountability, predictability, and transparency through such improvements as a more structured presubmission process and earlier interactions between FDA and applicants. With the additional funding, the FDA would be able to hire more than 200 full-time equivalent workers by the end of the five-year program.
