As part of U.S. Food and Drug Administration’s (FDA) overall effort to deliver safe and effective medical devices to patients and health care professionals as quickly as possible, including products incorporating cutting-edge technology, the agency is proposing recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA II). FDA is accepting public comments on its proposal for the next 30 days.
The Medical Device User Fee and Modernization Act of 2002, which expires on Sept. 30, 2007, amended the federal Food, Drug and Cosmetic Act to provide FDA with new responsibilities and resources to keep up with the rapidly growing device industry and changing medical device technology.
Under the MDUFMA program, FDA collects fees from manufacturers seeking to market medical devices, which helps the agency improve the timeliness, quality and predictability of its overall pre-market review program. The new legislative package specifies industry would provide total fee revenues of $287 million over the next five years. These fees will supplement appropriations provided by Congress.
FDA PERFORMANCE GOALS
FDA is proposing to meet more rigorous goals for reviewing medical devices that build on the progress of the first medical device user fee program.
For example, FDA would reach a decision on 50 percent of expedited pre-market approval (PMA) applications and expedited supplement applications within 180 days; 90 percent within 280 days. In addition, FDA would reach a decision on 90 percent of 510(k) applications within 90 days; 98 percent within 150 days.
FDA would report on how it is meeting these performance goals on a quarterly basis.
HELP FOR SMALL BUSINESSES
Since a significant portion of medical device manufacturers are considered small businesses, FDA would provide them with additional financial relief, including:
- no fees for first-time PMA submissions to small businesses with $30 million or less in annual sales or receipts;
- further reductions in full fees for 510(k) application submissions (from 80 percent to 50 percent) and for PMA submissions and related supplements (from 38 percent to 25 percent) for small businesses with $100 million or less in annual sales or receipts; and
- a provision for foreign business entities to qualify as small businesses.
Manufacturers would continue to pay fees when they submit applications for some types of medical devices, but at a lower and more stable rate than under the current program. The proposal would add several additional fees, which would generate about 50 percent of the total fee revenue and be more stable than application fees. A fee would be assessed on facilities that register with FDA as a medical device manufacturer and for the filing of an annual report for PMAs.
FDA’s proposal would also: continue to foster interactive reviews between the agency and manufacturers; streamline the third party inspection program to make it easier for companies to participate in the program; and foster the development of innovative in vitro diagnostic tests.