Public Workshop: Medical Device User Fee Program Public Meeting, September 14, 2010

NOTE: The Food and Drug Administration (FDA) is extending to November 1, 2010, the comment period for the notice that appeared in the Federal Register of Friday, August 13, 2010 (75 FR 49502).

October 14: Added Transcript
September 9: Added Live Webcast, updated Agenda, extended registration up to the day of the event
August 27: Added Webinar Presentations 

The purpose of the workshop is to provide an opportunity for stakeholders to present their views on the medical device user fee program. We welcome this opportunity to hear from stakeholders as we begin the next reauthorization process.

• Date, Time and Location
• Background
• Webinar and Video Presentatons
• Federal Register Notice
• Agenda
• Transcript (PDF)
• Public Comment
• Contact Us

Date, Time and Location

The meeting was held at:

The Marriott Inn and Conference Center, UMUC
3501 University Blvd E
Hyattsville, MD 20783
Phone: 301-985-7300
www.marriott.com/wasum

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Background

The Food and Drug Administration (FDA) is announcing a public meeting on the medical device user fee program, originally enacted in the Medical Device User Fee and Modernization Act (MDUFMA), and renewed in the Medical Device User Fee Amendments of 2007 (MDUFA). The legislative authority for the medical device user fee program expires in September 2012. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on medical device user fee program reauthorization, we hold a public meeting at which the public may present its views on the reauthorization and provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes. FDA invites public comment on the medical user fee program and suggestions regarding the commitments FDA should propose for the next reauthorized program.

In the years preceding enactment of Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250), FDA’s medical device program suffered a long-term, significant loss of resources that undermined the program’s capacity and performance. MDUFMA was enacted “in order to provide the Food and Drug Administration (FDA) with the resources necessary to better review medical devices, to enact needed regulatory reforms so that medical device manufacturers can bring their safe and effective devices to the American people at an earlier time, and to ensure that reprocessed medical devices are as safe and effective as original devices.”¹ MDUFMA had a 5-year life and contained two particularly important features which relate to reauthorization:

• User fees for the review of medical device premarket applications, reports, supplements, and premarket notification submissions provided additional resources to make FDA reviews more timely, predictable, and transparent to applicants. MDUFMA fees and mandated appropriations for the medical device program, helped FDA expand available expertise, modernized its information management systems, provided new review options, and provided more guidance to prospective applicants. The ultimate goal was to approve and clear safe and effective medical devices more rapidly, benefiting applicants, the health care community, and most importantly, patients.
   
• Negotiated Performance goals for many types of premarket reviews provided FDA with benchmarks for measuring review improvements. These quantifiable goals became more demanding each year and include FDA decision goals and cycle goals (cycle goals refer to FDA actions prior to a final action on a submission). Under MDUFMA, FDA must also have met several other commitments that do not have specific time frames or direct measures of performance, such as expanding the use of meetings with industry, maintenance of current performance in review areas where specific performance goals have not been identified, and publication of additional guidance documents. 

Medical device user fees and increased appropriations were viewed by FDA, Congress, and industry stakeholders as essential to support high-quality, timely medical device reviews, and other activities critical to the device review program.

MDUFMA provided for fee discounts and waivers for small businesses. Small businesses make up a large proportion of the medical device industry, and these discounts and waivers helped reduce the financial impact of the user fees on this sector of the device industry, which plays an important role in fostering innovation.

The negotiated performance goals and commitments that did not have specific time frames or direct measures of performance set under MDUFMA were comprehensive and demanding. By FY 2007, a total of 85 performance goals and commitments were in effect. FDA provided periodic reports on its progress towards meeting these performance goals and commitments to its stakeholders and Congress. FDA also provided an annual financial report to Congress to help ensure transparency and accountability of its use of the additional resources provided by MDUFMA.

In 2007, Congress reauthorized medical device user fees through fiscal year 2012 under the Medical Device User Fee Amendments of 2007(MDUFA) (title II of the Food and Drug Administration Amendments Act of 2007(FDAAA) (Public Law 110-85).

Under MDUFA, the user fee program remained intact, with a few significant modifications to the program. The user fee framework was changed to provide a more reliable and stable funding stream. Specifically, MDUFA included establishment registration as a new fee type which provided a more predictable amount of funds that could be collected by the Agency in any given year. MDUFA also saw changes to the performance goals. Compared to MDUFMA, there were fewer performance goals under MDUFA, yet the goals were more demanding. Specifically, individual cycle goals were removed and tighter overall goals were implemented. This was done to facilitate a more interactive review process. Specific timelines were established under MDUFA for Modular PMAs and Real-Time PMA supplements, which were not established under MDUFMA in 2002.

The purpose of the upcoming meeting is to hear stakeholder views on medical device user fee reauthorization as we consider the features to propose in the next medical device user fee program. FDA is interested in responses to the following two general questions and welcomes any other pertinent information stakeholders would like to share:

1. What is your assessment of the overall performance of the medical device user fee program thus far?
2. What aspects of the medical device user fee program should be retained, changed, or discontinued to further strengthen and improve the program?

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Webinar and Video Presentations

This meeting will be webcast live at:
http://fda.yorkcast.com/webcast/Viewer/?peid=79f5888a2ebc4ceca371c31e83ac957f

In addition, the following video presentations on the medical device user fee program are designed to give the public more background information on the program. These pre-recorded seminars are in Windows Media Video format, are free of charge, and can be viewed at any time.

• Overview of User Fees and the Reauthorization Process (Malcolm Bertoni)
  This presentation provides a general overview of what user fee programs are, how user fee programs work at the U.S. Food and Drug Administration (FDA), and the process to be followed as we work to support congressional reauthorization of the Medical Device User Fee Program in the year 2012. The presentation provides a general overview of how we will engage various stakeholder groups in the reauthorization process, beginning with the September 14, 2010 Medical Device User Fee Program’s Public Meeting.
• Device Development and Activities Supported by the Medical Device User Fee Program (Donald St. Pierre)
  This presentation provides an overview of how FDA regulates all types of medical devices and the role of the medical device user fee program in the process.
• Medical Device Review Program Performance (Barbara Zimmerman)
  This presentation provides a history of the evolution of the medical device user fee program. It also includes a detailed review of FDA’s medical device review performance under the current medical device user fee program which runs from 2007 through 2012.

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Agenda

September 14, 2010

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Transcripts

• Transcript (PDF)

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Public Comments

The Food and Drug Administration (FDA) is extending to November 1, 2010, the comment period for the notice that appeared in the Federal Register of Friday, August 13, 2010 (75 FR 49502).

Any person may submit written or electronic comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 http://www.regulations.gov. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number [Docket No. 2010–N–0389]. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. To ensure consideration, all comments must be received by November 1, 2010.

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Contact

James Swink, Food and Drug
Administration, Center for Devices &
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, rm. 1609,
Silver Spring, MD 20993,
301–796–6313,
FAX: 301–847–8121,
James.Swink@fda.hhs.gov

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¹ H.R. Rep. No. 107-728, at 21 (2002).