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U.S. Department of Health and Human Services

Medical Devices

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Minutes from Stakeholder Meeting on MDUFA III Reauthorization, January 13, 2011

Stakeholder Meeting on MDUFA III Reauthorization
January 13, 2011, 9:00-11:00am
FDA White Oak Campus, Silver Spring, MD
Building 31, Room 1503

Purpose

To discuss the current status of the medical device user fee program, review stakeholder perspectives shared at the September 14th public meeting and docket submissions, and plan topics for future stakeholder discussions.

Participants

FDA

  • Bryan Benesch - Center for Devices and Radiological Health (CDRH)
  • Malcolm Bertoni - Office of the Commissioner (OC)
  • Ashley Boam - CDRH
  • Nathan Brown - Office of Chief Counsel (OCC)
  • Helene Clayton-Jeter - Office of Special Health Issues (OSHI)
  • Kate Cook - Center for Biologics Evaluation and Research (CBER)
  • Natalia Comella - CDRH
  • Sharon Davis - CDRH
  • Brenda Evelyn - OSHI
  • Christy Foreman - CDRH
  • Cindy Garris - CDRH
  • Elizabeth Hillebrenner - CDRH
  • Barbara Myklebust - CDRH
  • Thinh Nguyen - OC
  • Synim Rivers - OSHI
  • David Shindell - CDRH
  • Don St. Pierre - CDRH
  • Ruth Watson - Office of Legislation (OL)
  • Barbara Zimmerman - CDRH

Stakeholders

  • James Baumberger - American Academy of Pediatrics
  • Cynthia Bens - Alliance for Aging Research
  • Paul Brown - National Research Center for Women & Families
  • Susan Campbell - WomenHeart
  • Eric Gascho - National Health Council
  • Hilary Hansen - Spina Bifida Association
  • Suzanne Henry - Consumers Union
  • Campbell Hutton - Juvenile Diabetes Research Foundation
  • Jeanie Kennedy - American Assn of Orthopedic Surgeons
  • Heidi Moline - Union of Concerned Scientists
  • Andrew Morris - United Spinal Association
  • Martha Nolan - The Society for Women's Health Research
  • Kate Ryan - National Women's Health Network
  • Roslyne Schulman - American Hospital Association
  • Lisa Swirsky - Consumers Union
  • James Sykes - The AIDS Institute
  • Cindy Tomlinson - American Society for Radiation Oncology
  • Roquell Wyche - Association of Black Cardiologists
  • Diana Zuckerman - National Research Center for Women & Families

Additional Registered Stakeholders

  • Amy Allina - National Women’s Health Network
  • Margaret Beardsworth - Pulmonary Hypertension Association
  • Colleen Briley - Strategic Healthcare
  • Diane Edquist Dorman - National Organization for Rare Disorders
  • Tamar Margarik Haro - American Academy of Pediatrics
  • Tim Hermes - Strategic Healthcare
  • Mellanie True Hills - StopAfib.org
  • Darby Hull - Consumer Federation of America
  • Katie Kroner - Pulmonary Hypertension Association
  • Lisa Levine - Sudden Cardiac Arrest Association
  • John Schall - Parkinson’s Action Network
  • Michelle Vogel - The Alliance for BioTherapeutics
  • Elisabeth Williams - Pulmonary Hypertension Association

Meeting Start Time: 9:15 am

Welcome

FDA began the meeting by welcoming stakeholders and discussing the purpose of these meetings as part of the reauthorization provisions specified in the FDA Amendments Act of 2007. These monthly meetings are meant to continue the discussions of stakeholder perspectives that began at the September 14, 2010, public meeting. These meetings also fulfill FDA’s statutory obligation to meet with patient and consumer advocacy groups during FDA’s negotiations with the regulated industry on reauthorization of the medical device user fee program as previously reauthorized under the Medical Device User Fee Amendments of 2007 (MDUFA). As a result, the subject of these meetings is reauthorization of MDUFA,

Background on MDUFA and Review of Stakeholder Perspectives

FDA discussed the MDUFA reauthorization process, which includes both negotiations with regulated industry and monthly meetings with specified stakeholders. This is the first monthly meeting with stakeholders. FDA’s objectives for the process are to obtain ongoing input from patient and consumer advocacy groups in the development of recommendations for MDUFA reauthorization, develop a common vocabulary for discussing MDUFA issues, develop a shared understanding of interests among stakeholders, and explain aspects of the medical device review program that are of interest to the stakeholders. FDA encouraged continuity of stakeholder engagement throughout the process.

FDA summarized comments from stakeholders received at the September 14, 2010 public meeting and in written docket submissions.

Stakeholder Introductions

Participants introduced themselves and stated the mission of the organization they represent.

Planning Topics for Future Meetings

Stakeholders were asked to review the summary of stakeholder comments and each table was asked prioritize their top three topics for future stakeholder meetings as a small group exercise. Participants, including those participating by teleconference, identified the following priorities, positions, and issues for future discussions:

  • There is a need for timely notification of healthcare providers when post-market problems are identified.
  • There is a need for guidance documents to encourage biomarker development for enrichment of clinical trials.
  • Premarket clinical trials should include populations such as women and the elderly.
  • There should be increased efficiency among FDA Centers as well as stakeholders in tackling disease specific topics (e.g., Alzheimer’s therapy development).
  • Clinical trials should be more stringent to produce higher quality of evidence for devices.
  • Stakeholders are concerned with the 510k process and potential upcoming changes to it. Recommendations were made for reclassifying devices based on what happens when they fail and for inspections of 510(k) manufacturers.
  • The FDA should increase post-market surveillance of device safety.
  • The FDA needs increased resources to serve their public health mission.
  • There should be greater transparency in FDA’s meetings with Industry. Stakeholders suggested that FDA make visitor logs accessible to public and post transcripts rather than minutes or summaries.
  • The FDA should explore the needs of pediatric patients and what incentives may be considered to achieve them.
  • The FDA should expand post-market surveillance, both in extent and length of follow-up. In particular, FDA should exercise their authority over post-market activities for pediatric patients under the Pediatric Medical Device Safety and Improvement Act.
  • Performance standards should include safety; not just speed.
  • User fees should be used to review direct to consumer advertising before it takes place.
  • Post-market studies are critical as they can tell us more about the real world, especially racial, ethnic, and age diversity.
  • User fees should be increased so that CDRH has adequate funding to evaluate safety and effectiveness of medical devices more swiftly.
  • The level of user fees for medical device submissions relative to the overall cost of review and relative to the proportion of review costs incorporated in prescription drug user fees.

FDA participants asked follow-up questions about some of the stated priorities, leading to general discussion.

Schedule of Future Meetings

FDA will follow-up with registered participants via e-mail to gather preferences on location for the next stakeholder meeting.

Meeting End Time: 11:00 am