Medical Device User Fee and Modernization Act
How will the MDUFMA have an impact on you, your device, and your industry?
To view the table related to this article, please refer to the print version of our October issue, page 55.
The views and opinions in this article are those of the authors and do not necessarily reflect those of the Food and Drug Administration, the US Department of Health and Human Services, or the Public Health Service.
WHAT IS MDUFMA?
Amendments to the 1938 Federal Food Drug and Cosmetic Act have served as the cornerstone of medical device regulations. Notable amendments include the Medical Device Amendments of 1976, the Safe Medical Device Act of 1990, and the FDA Modernization Act of 1997. The most recent amendment, the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), has taken center stage in the medical device arena.
President George W. Bush signed MDUFMA into law on October 26, 2002. However, it has only been in the last several months that more notable requirements of MDUFMA have been implemented. Although MDUFMA institutes many changes that will have a large impact on the regulation of medical devices, the most immediate and furthest reaching in scope will likely be user fees. Other significant changes concern third-party inspections, combination products, and reprocessed single-use devices.
In order to market a medical device, the Food and Drug Administration (FDA) must review a premarket approval application (eg, PMA) or a premarket notification [510(k)], that is, unless the device is exempted from this requirement. Beginning April 1, 2003, the Food and Drug Administration will not review a premarket approval application or 510(k) without first receiving payment of a user fee from the sponsor of the application. Companies must also pay a user fee for various supplements associated with these premarket applications.
Resources for the FDA’s medical device program have been reduced in recent years and there were concerns that this may ultimately lead to a decline in review performance. It is believed by some that user fees will provide the FDA with the means to push toward more rigorous performance goals—namely, more timely and interactive reviews. This will be achieved by applying user fee revenues to certain programs such as reviewer training and increased FDA use of outside experts, as well as the hiring of additional FDA personnel in key areas. More timely and interactive reviews may lead to safe and effective devices entering the market more quickly. MDUFMA also requires the FDA to submit annual reports of performance to Congress in order to assess the impact of user fees on review times. There will also be studies by the General Accounting Office to assess the impact of user fees on review performance.
There are certain premarket applications that are exempt from the user fees. These include Humanitarian Device Exemptions (HDEs), which are intended to treat a small population, a company’s first premarket application, third-party reviewed 510(k)s, any application for a device intended solely for pediatric use, and any application from a state or federal government agency. Small companies (those that have revenue of $30 million or less on their most recent federal income tax return) will be granted a 38% fee reduction. A company must submit their tax returns and qualify as a small business 60 days prior to submission of the application. If the 38% fee reduction granted to small companies results in a decrease in total user fee revenues of greater than 16%, the FDA may raise the revenue ceiling for small companies so that fewer companies qualify.
The user fees will be adjusted each year to reflect changes in the number of submissions received, inflation, and other factors. The FDA will announce changes in fees for the next fiscal year by August 1 of each year in the Federal Register. On July 31 of this year, the FDA published the fiscal year 2004 user fees. Table 1 details the user fees for fiscal years 2003 and 2004.
Manufacturers of certain types of medical devices must have their facilities inspected before they can market their device, in addition to having their premarket application reviewed by the FDA. In the past, the FDA’s Office of Compliance was solely responsible for this task. MDUFMA allows for certain types of class II and class III device manufactures to be inspected by third parties. Third parties are FDA-accredited bodies that are not affiliated with the FDA or the manufacturer. The allowance of third-party inspections is intended to enable the FDA to concentrate its inspection resources on the facilities that may present the most risk to consumers.
The provision contains many qualifiers. Notably, to qualify for third-party inspection, the company must have had a previous inspection by the FDA that was classified “no action indicated.” The manufacturer must also petition the FDA for use of a third party and wait for the request to be granted or denied. Additionally, the manufacturer must market the device in the US and must also market, or intend to market, the device in a country that recognizes FDA-accredited third parties.
A copy of the third-party inspection report must be provided to the FDA within 3 weeks of the inspection. The FDA will periodically audit third-party inspectors to ensure compliance with accreditation standards.
The FDA expects to receive an increasing number of combination products. This is primarily due to new technologies that allow for the merging of the therapeutic areas of devices, drugs, and biologics. Examples of these therapies include drug delivery devices and drug- or biologic-coated devices (such as the drug-eluting stent). These particular therapies present unique challenges from an FDA review standpoint. With multiple centers within the FDA (Center for Biologics Evaluations and Research, Center for Devices and Radiological Health, and Center for Drug Evaluation and Research), questions arise concerning how and by whom the review process of combination products should be managed.
Prior to MDUFMA, the manufacturer generally sent combination product submissions to the center at the FDA that they felt was appropriate. That center would then determine whether or not it would review the application. To help provide consistency and clarity regarding the regulation of combination products, MDUFMA required that a new office, the Office of Combination Products (OCP), be established.
The OCP has been developed to ensure timely, effective, and consistent premarket review of combination products by a variety of methods. The OCP will determine which FDA center should have primary jurisdiction over the review. In addition, the OCP will oversee the reviews involving more than one agency center and coordinate developing and updating guidance documents for combination products and other regulatory or policy issues related to combination devices.
REPROCESSED SINGLE-USE DEVICES
Currently, there are reprocessed single-use devices that require premarket notification or approval [eg, 510(k) or PMA] and reprocessed single-use devices that are exempt from any premarket clearance. Examples of single-use devices that are commonly reprocessed are percutaneous transluminal angioplasty catheters and guidewire catheters. MDUFMA calls for some changes to the regulations of these reprocessed single-use devices. For example, all reprocessed single use-devices that are marketed after January 25, 2004, will have to bear the statement: “Reprocessed device for single use. Reprocessed by (name of company that reprocessed the device).”
Additionally, many reprocessors of certain critical single-use devices that were previously exempt from submitting a 510(k), as well as many devices that are currently subject to 510(k), will need to submit validation data. Validation data will be necessary to show that the reprocessed device will perform acceptably after the maximum intended reprocessing cycles. Also, reprocessors of class III devices will need to submit a new type of premarket application called a premarket report. The premarket report will contain similar information as required in a PMA.
It is apparent that the MDUFMA will have a dramatic impact on the medical device industry, as well as the FDA. Although a few of the provisions have been briefly discussed here, there are many other changes outlined by MDUFMA that are beyond the scope of this article. Additional information on the MDUFMA can be found at http://www.fda.gov/cdrh/mdufma.
Dorothy B. Abel is a Regulatory Review Scientist with the US FDA Center for Devices and Radiological Health in Rockville, Maryland; she is also a regular columnist for Endovascular Today. Ms. Abel may be reached at (301) 443-8262, ext. 165; firstname.lastname@example.org.
Garrett P. Pilcher is currently a Master’s Candidate in Regulatory Science at the University of Southern California School of Pharmacy.