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FDA Announces Recommendations to Reauthorize Medical Device User Fee Program

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.

The FDA 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.

Under this program, industry covers a portion of the costs of FDA's pre-market review program through a variety of fees. The fees are used to help FDA meet its review performance goals. The industry user fees represent less than a quarter of the overall device budget for MDUFMA II.

The following are the key components of the proposal.

Fee Structure

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. An additional fee would be assessed on facilities that register with FDA as a medical device manufacturer. Annual report filing fees would also be collected for pre-market approvals.

Performance Goals

The additional revenues generated from this proposed program 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.
Small Business Relief

Small businesses would 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.

Greater Transparency

To achieve greater transparency, FDA would continue to foster interactive review by encouraging informal communication with companies; facilitate the timely scheduling meetings; expand the kinds of performance information FDA makes available to the public; enhance opportunities 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 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.

For more information, visit www.fda.gov/cdrh/mdufma/

If you have comments regarding this update, please contact Romil Rambhia at 516-482-9001 or email at romil@mdiconsultants.com

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