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The Food and Drug Administration (FDA) today proposed recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA II), which, if adopted, would help to ensure that safe and effective medical devices get to patients in a timely manner. FDA is accepting public comments on the proposal for the next 30 days and is holding a public meeting on April 30.
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 are used in concert with the agency's annual appropriations to help FDA meet its review performance goals, which would speed more promising products to market than before. 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. "We look forward to working with Congress on this proposal."
The following are the key components of the proposal:
MDUFMA II would provide industry with predictable and more stable fees because the amount for each type of fee for each year of the program 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. A fee would be assessed on facilities that register with FDA as a medical device manufacturer. In addition, annual report filing fees would be collected for pre-market approvals.
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. For example, FDA would reach a decision on 50 percent of expedited pre-market applications and expedited supplement applications that go before an FDA advisory committee within 180 days; 90 percent within 280 days. FDA would reach a decision on 60 percent of conventional pre-market applications and supplement applications that go before an FDA advisory committee within 180 days; 90 percent within 295 days. In addition, FDA would reach a decision on 90 percent of 510(k) applications (lower-risk devices) within 90 days; 98 percent within 150 days.
FDA would report on how it is meeting these performance goals on a quarterly basis.
Small Business Relief
Small businessesa significant portion of device manufacturerswould see additional benefits under the proposal. 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 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 would allow a mechanism for foreign businesses to qualify as small businesses.
To achieve greater transparency, FDA would continue to foster interactive review by encouraging informal communication with companies; facilitate the timely scheduling of informal and formal meetings; expand the kinds of performance information FDA makes available to the public; enhance opportunities for stakeholders to provide input into guidance document development; facilitate the development of guidance to streamline the processes and to clarify the data requirements for the approval or clearance of imaging devices that use contrast agents or radiopharmaceuticals.
Accredited Third Party Inspection Program
The proposal would streamline the third party inspection program, which allows for the use of 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 inspectional resources based on risk.
In Vitro Diagnostic Devices
MDUFMA II would foster the development of innovative 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. In addition, FDA would conduct a pilot program under which the agency would review simultaneously a company's 510(k) and waiver applications under the Clinical Laboratory Improvement Amendments, the law that governs quality standards for all laboratory testing.
A notice is on display in today's Federal Register. The public meeting where FDA will present its MDUFMA II proposal will be held at 5630 Fishers Lane, Room 1066, Rockville, Md. After all public comments are evaluated and any appropriate changes made, a final proposal will be submitted to Congress. MDUFMA reauthorization would go into effect only after enacted by Congress and signed by the President.
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), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Md., 20852. Comments must include docket number 2007N-0068.
The Medical Device User Fee and Modernization Act of 2002, which expires on Sept. 30, 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.