New recommendations, agreed to by the FDA and representatives from the medical device, would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation.
The industry associations who have reached an agreement in principle with the FDA include the Advanced Medical Technology Assoc., the Medical Device Manufacturers Assoc. and the Medical Imaging and Technology Alliance.
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 agreement strikes a careful balance between what industry agreed to pay and what the FDA can accomplish with the amount of funding proposed, according to a statement from the FDA. A more more structured pre-submission process and earlier interactions between FDA and applicants is expected to results in greater accountability, predictability and transparency.
The FDA and industry expect that the agreement in principle would result in a reduction in average total review times.
The new funding will support over 200 new workers by the end of the five-year program.
"Reauthorization of this important program is an essential component for advancing medical device innovation," said FDA Commissioner Margaret A. Hamburg, M.D.
Congress first established the user fee program 10 years ago with the Medical Device User Fee and Modernization Act of 2002 (MDUFA I), prompted by growing concerns about the capacity and performance of the medical device review program. The five-year program was reauthorized with the Medical Device User Fee Act of 2007 (MDUFA II) and is set to expire on Sept. 30.
MDUFA II authorized FDA to collect user fees for certain medical device applications, for the registration of certain medical device establishments, and for certain other purposes. Small businesses may qualify for a waiver from fees on certain submissions or may qualify for a reduced fee.
Once the final details of the agreement with industry is completed, FDA will develop a package of proposed recommendations and give the public an opportunity to comment before they are submitted to Congress.
