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FDA Meets with Stakeholders to Address Issues Related to the Implementation of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA)

On December 3, 2003, FDA’s Center for Devices and Radiological Health (CDRH) and its Center for Biologics Evaluation and Research (CBER) held their First Annual Stakeholder Meeting related to the implementation of the Medical Device User Fee and Modernization Act of 2002, known as MDUFMA. FDA is seeking feedback from stakeholders during the implementation process to execute the programs and requirements of MDUFMA as effectively as possible.

The long-term goal of MDUFMA is to provide FDA’s medical device program with sufficient resources to ensure that safe and effective new products get to consumers as quickly as possible. Enhanced staffing, increased training, and better infrastructure will help FDA work more interactively and efficiently with submitters to shorten development and review time for life saving medical technologies by 2007.

FDA held this stakeholder meeting as part of its commitment to move ahead aggressively to implement the MDUFMA process fully. Already, the program is showing some short-term benefits, and FDA has made progress toward even greater long-term improvements.

During Fiscal Year 2004, for example, FDA expects to spend user fees to add more than 100 additional staff, who will be fully trained and fully engaged in the review process. These new staff members will conduct and support medical device reviews, so that the agency can meet the challenging performance goals associated with this program and ultimately help industry speed the development and marketing of safe and effective new products.

MDUFMA: The First Year

The goals of MDUFMA give FDA the necessary start-up time to build infrastructure, hire, and train staff, to be able to meet performance targets that generally become applicable in 2005. As was the case with the Prescription Drug User Fee Act ten years ago, the agency utilized the first year of MDUFMA to set up the User Fee Program and establish necessary systems and procedures.

MDUFMA established ten statutory deadlines in the first year, and FDA has met all of them. Most of these requirements dealt directly with provisions of the statute other than user fee performance goals. For example, during the first year FDA

• established and staffed a new Office of Combination Products to ensure the most efficient review of products that contain a device as well as a drug or biologic component;
• published accreditation criteria, reviewed applications, and accredited 15 third parties to perform inspections;
• published a list of reprocessed single-use devices that will be subject to additional premarket requirements;
• published guidance for the submission of applications for pediatric products and for protection of children during clinical trials with medical devices.

FDA also published a number of additional guidances on a variety of the MDUFMA provisions to train staff and help industry understand the agency’s process for implementing MDUFMA, including the various user fee provisions. A complete list of the guidances available, as well as other information about MDUFMA implementation, can be found at www.fda.gov/cdrh/mdufma/index.html.

To provide feedback to the many parties with a stake in the success of MDUFMA, including Members of Congress, FDA has several mechanisms to report on its MDUFMA progress for Fiscal Year 2003.

The performance report being prepared for Congress will show that, while there are some measures that indicate the agency is close to meeting some of the statutory goals reiterated in the MDUFMA goals letter, the goals that emphasize a complete review early in the process will require significant improvement. This is particularly true with respect to breakthrough technologies, or expedited review products, which is the area where the agency has committed to the most significant changes.

Although performance in all areas has not changed dramatically during this start up year, the agency has taken a number of steps that will contribute to its ability to meet the aggressive goals that become effective in 2006 and 2007. In addition to establishing payment, billing, and small business designation procedures for the user fee program, FDA has invested user fee and appropriated dollars in a number of ways that will contribute to the ultimate improvement in the review process in later years. Among other actions, CDRH

• has hired project managers for each product review group to ensure that the review process runs as efficiently as possible from the time an applicant meets with FDA;
• has hired more than 50 new scientific, medical, engineering, and other review staff, including 14 new statisticians who will be able to contribute their expertise to the review process;
• has developed a growing medical device fellowship program that hires outside clinical and academic experts to participate in FDA review work and train FDA staff, particularly in the field of cardiovascular technology;
• has developed process improvements to speed review from beginning to end, including a filing review guidance to ensure that submissions come in with the necessary information for complete review and a continuous improvement project to streamline the steps to closeout an agency decision following Panel recommendation.

In addition, the CBER report to Congress on that Center’s work during the first year of MDUFMA indicates that the device program in biologics has already improved its timeliness and responsiveness.

FDA’s financial report to Congress (required under MDUFMA) is due by January 2004, and FDA will make that report publicly available as soon as possible.

Highlights of what FDA expects to report include:

• Total FY 2003 collections were $21.9 million.
• This is $2.3 million more than estimated in the August 1, 2003 Federal Register notice which set fees for FY 2004.
• FY 2003 collections were still $3.2 million less than the revenue target of $25.1 million for Fiscal Year 2003 which was set in the MDUFMA statute.
• Since the final amounts collected in FY03 exceeded the amount anticipated when the fees were set in August, any collections over $31.6M in FY04 would be credited to the amounts that industry would be required to pay in FY 05.

Every year FDA publishes financial statements that are audited annually by an outside third-party under the requirements of the Chief Financial Officers (CFO) Act. This is a rigorous and complete audit that tests all of our financial systems and programs and covers all components of our financial systems, including our accounting for user fee funds collected and expended. The FY 2003 audit is nearing completion, and we expect to get the audit results for FY 2003 before the end of December. Shortly after we get the audit results, we will post the FY 2003 financial statements and auditor’s opinion on our web site at www.fda.gov/cdrh/mdufma/index.html.

FDA has consistently received “unqualified” opinions-the most favorable category-in all audits since FY 1998.

In addition to this annual third-party financial audit under the CFO Act, the trigger provisions of MDUFMA require that another independent third-party, the Comptroller General of the United States, perform an independent study and report to Congress for FY 2003 and FY 2004 if the appropriation for FDA’s device and radiological health program are less than MDUFMA requires. That was the case in FY 2003, and will be the case in FY 2004. We expect to be the subject of this MDUFMA-required GAO study soon.

The December 3rd Meeting with Stakeholders

The stakeholders meeting provided the opportunity for all interested persons to provide information and discuss the user fees and other aspects of the implementation of MDUFMA. This one-day meeting consisted of five panel sessions that included panelists from FDA, industry, and other stakeholders, followed by public presentations and a question and answer period from the audience at the end of each panel. The panel topics were:

Panel 1: “How is the User Fees Process Working?” considered the financial aspects of the user fee process and performance goals.

Panel 2: “Electronic Labeling and Identification of the Manufacturer on the Device,” addressed electronic labeling for prescription devices intended for use in healthcare facilities and the requirement that the manufacturer be identified on the device.

Panel 3: “Bundling, Modular PMA, and Expedited PMAs,” discussed Agency guidances that address various PMA issues, including bundling multiple devices/indications for use in a single application, modular PMAs, and expedited review procedures for certain marketing applications.

Panel 4: “Third-Party Inspection Program,” discussed implementation of the program, including eligibility criteria for use of a third party by a manufacturer.

Panel 5: “Reuse,” discussed FDA-identified reprocessed single-use devices that will require premarket submission of validation data and the associated guidance for submission of data.

For those who could not attend in person, the agency provided the opportunity to listen from a remote location via Audio Conferencing to the live proceedings of the meeting. The meeting is being transcribed so that FDA and our stakeholders have a record of the comments about the implementation process. The transcripts will be made available through FDA Dockets sometime in January 2004.

The agenda and presentation materials are posted to the CDRH MDUFMA webpage. FDA encourages all stakeholders to provide information and views about the implementation of the new law. Comments about the meeting or any other aspects of MDUFMA implementation can be sent to the agency’s MDUFMA docket (Docket No. 02N-0534).

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