The FDA proposed recommendations to congress for reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA II). The proposal would help ensure that safe and effective medical devices get to patients in a timely manner.
Under the medical device user fee program, the medical device industry contributes some of the costs of FDA's pre-market review program, which are combined with the agency's annual appropriations. The industry user fees represent less than a quarter of the overall device budget for MDUFMA II.
"The proposal would give companies predictable fees and improved review times as well as provide FDA with a steady source of additional funding for its device review program," said Andrew C. von Eschenbach, MD, commissioner of Food and Drugs.
Key proposal components are as follows:
- MDUFMA II would provide the industry with predictable and more stable fees that would be prescribed in the statute;
- Manufacturers would 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 would also provide for additional fees;
- The additional revenues generated from fees paid by the medical device industry would continue to be used to ensure patients have timely access to safe and effective medical devices. FDA would report on how it is meeting these performance goals on a quarterly basis;
- The fees currently paid by businesses with $100 million or less in annual sales or receipts would be reduced from 80 percent of the full fee in the first device user fee program to 50 percent for 510(k) applications, and from 38 percent to 25 percent for pre-market approvals and related supplement fees;
- FDA would provide interactive review by encouraging informal communication with companies;
- The proposal would streamline the third party inspection program, by making it easier for manufacturers to participate in the program; and
- MDUFMA II would also encourage the development of in vitro diagnostic tests by issuing new industry guidance on important emerging issues and reviewing some low-risk devices to determine whether any of them could be exempted from the need for product review;
FDA is accepting public comments on the proposal for the next 30 days and is holding a public meeting on April 30. To submit electronic comments on the proposal, visit www.regulations.gov or www.fda.gov/dockets/ecomments . Written comments may be sent to: Division of Dockets Management (HFA-305), U.S. Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Include docket number 2007N-0068.
For more information regarding The Medical Device User Fee and Modernization Act of 2002, which expires on Sept. 30, visit www.fda.gov/cdrh/mdufma/.