“Reauthorization of this important program is an essential component for advancing medical device innovation,” FDA Commissioner Dr. Margaret Hamburg said in a news release.
The FDA said that it will collect $595 million in user fees from the device industry over a five-year period. Further details about the fee structure have not been finalized, although the FDA said it plans to hire 200 full-time workers during the five years.
The Advanced Medical Technology Association said in a separate release that the agreed-upon performance goals require the FDA to reduce total review times, meet with companies to work on submissions with missing information, contact applicants halfway through the review and hire an independent consulting firm to analyze the FDA's management of the review process.
User fees, which are paid by the industry, are used to fund the FDA's review processes. In exchange, the agency will agree to meet performance goals that the industry agrees to. The Medical Device User fee Act of 2007 is set to expire Sept. 30.
The House Energy and Commerce Health Subcommittee has scheduled hearings this month about the prescription drug, generic drug and medical device user-fee programs.