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News Release

HHS WELCOMES PASSAGE OF DEVICE USER FEE LEGISLATION

The Department of Health and Human Services (HHS) welcomes the passage of legislation that would provide the Food and Drug Administration's (FDA) device review program with the same type of successful funding system that has been used over the last decade for the agency's drug and biologics reviews. Under this system, device manufacturers would pay fees to FDA for the review of their new product applications, and these funds would, in turn be used specifically to enhance FDA's devices review program.

"FDA's successful user fee program for pharmaceuticals has shown that a good user fee program can reduce time to market for safe and effective products without compromising safety and effectiveness, said HHS Secretary Tommy G. Thompson.

The bill, the Medical Device User Fee and Modernization Act of 2002, would establish a user fee program for medical devices, and further amend the Federal Food, Drug, and Cosmetic Act to, among other things, establish a third party inspection program and revise the regulatory scheme for reprocessed single use devices. The main goal of these measures is to improve FDA's ability to provide access to safe and effective medical devices.

"Congratulations to Representatives Tauzin and Bilirakis and Senators Gregg and Kennedy for their leadership in passing this legislation," Secretary Thompson said.

Under the user fee program, the medical device industry would pay reasonable fees for FDA review of device applications. The agency would use those fees to improve timeliness, quality, and predictability of reviews, particularly for breakthrough technologies.

Both consumers and the medical industry will benefit from device user fees. A stable source of funding will enable FDA to expedite approval of medical devices, and thus reduce time to market for industry and give consumers earlier access to innovative treatments, with greater choice among products. User fees will also foster innovation in medical technology by providing industry with predictability, timeliness, and sound science in review of applications for new devices.

Under the third party inspection program, manufacturers with a good compliance history would be permitted to select an FDA-accredited, non-government entity to perform quality systems inspections. FDA currently performs these inspections. Such a program should increase inspections of device firms and permit FDA to focus its inspection resources on firms with greater problems and devices that pose greater risks.

The bill contains stringent conflict of interest standards to ensure that third parties have no financial interest in the firm or products being inspected, or any product that FDA regulates. It also contains auditing requirements and procedures for withdrawal of accreditation for firms that no longer qualify for the program and debarment of accredited persons.

The bill also makes changes to ensure that a reprocessed medical device will be as safe and effective as the device that has not been reprocessed. It is intended to provide users with information about whether the devices they use are or are not reprocessed and to provide FDA with adequate information about whether medical devices can be cleaned, sterilized, and reprocessed without adversely affecting their performance.

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Note: All HHS press releases, fact sheets and other press materials are available at www.hhs.gov/news.

Last Revised: October 18, 2002