The FDA proposed recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA II). Under the medical-device user-fee program, industry covers a portion of the costs of FDA's pre-market review program through a variety of fees. The fees help the FDA meet its review performance goals, which would speed more promising products to market than before. Industry user fees represent less than a quarter of the overall device budget for MDUFMA II.

Some of the proposal's highlights include:

A new fee structure in MDUFMA II will provide industry with predictable and more stable fees because the amount for each category for each year of the program would be prescribed in the statute. Manufacturers will continue to pay fees when they submit applications for some types of medical-device applications, but at a lower rate than under the current program. The proposal also includes additional fees. For example, an annual fee will be assessed on facilities that register with the FDA as a medical-device manufacturer. In addition, annual report filing fees would be collected for pre-market approvals.

Performance goals for the FDA means the additional revenues generated by the fees will continue to ensure patients have timely access to safe and effective medical devices. For example, the FDA would have to reach a decision on 50% of expedited pre-market applications and supplement applications that go before an FDA advisory committee within 180 days. The FDA will be expected to reach a decision on 60% of conventional pre-market applications and supplement applications that go before an FDA advisory committee within 180 days.

Small-business relief spells additional benefits for those companies and a significant portion of device manufacturers. The fees currently paid by businesses with $100 million or less in annual sales or receipts will go from 80% of the full fee in the first user-fee program to 50% for 510(k) applications. Fees are reduced from 38% to 25% for pre-market approvals and related supplement fees. The FDA will continue to waive the fee for all first-time pre-market approval applications for businesses with $30 million or less in annual sales or receipts. In addition, the proposal allows a mechanism for foreign businesses to qualify as small businesses.

An accredited third-party inspection program would streamline the third-party inspection program, which allows using accredited private sector auditors for routine inspections by making it easier for manufacturers to participate in the program. Such inspections augment rather than substitute for FDA oversight and facilitate FDA's ability to allocate its inspection resources based on risk.

Find out more information on the MDUFMA II Web site www.fda.gov/cdrh/mdufma/mdufmaii-factsheet.html