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Medical Devices

Minutes from Stakeholder Meeting on MDUFA III Reauthorization, May 19, 2011

Stakeholder Meeting on MDUFA III Reauthorization
May 19, 2011, 1:30 – 3:30 PM
HHS Humphrey Building, Washington, DC
Room 305A


To provide an update of FDA’s negotiations with Industry and to receive stakeholder input on FDA proposals.



Malcolm Bertoni Office of the Commissioner (OC)
Bryan Benesch Center for Devices and Radiological Health (CDRH)
Nathan Brown Office of Chief Counsel (OCC)
Kate Cook Center for Biologics Evaluation and Research (CBER)
Natalia Comella CDRH
Sharon Davis CDRH
Christy Foreman CDRH
Cindy Garris CDRH
Michelle McMurry-Heath CDRH
Barbara Myklebust CDRH
Arleen Pinkos CDRH
Don St. Pierre CDRH
Ruth Watson Office of Legislation (OL)
Barbara Zimmerman CDRH


Paul Brown National Research Center for Women & Families
Lisa Chiarello National Multiple Sclerosis Society
Eric Gascho National Health Council
Joseph Isaacs United Spinal Association
Catherine Jeakle Hill American Association of Neurological Surgeons
Jeanie Kennedy American Academy of Orthopedic Surgeons
Jenny Liljeberg American Society of Cataracts and Refractive Surgery
Martha Nolan Society for Women’s Health Research
Rebecca O’Connor Parkinson’s Action Group
Kate Ryan National Women’s Health Network

Additional Registered Stakeholders

Darby Hull Consumer Federation of America
Melanie True-Hills
Campbell Hutton Juvenile Diabetes Research Foundation
Cindy Tomlinson American Society for Radiation Oncology

Meeting Start Time: 1:45 pm


FDA provided an update of FDA’s discussions with Industry, including the May 4, 2011 meeting with Industry.

FDA answered questions from stakeholders regarding the discussions with Industry, including questions regarding proposals for reauthorization, laboratory developed tests (LDTs), and the timeline for completing negotiations.

Stakeholders asked follow-up questions pertaining to: the clinical investigator list proposal, the status of the third party review process, the inclusion of a proposal on bundling and multiplex devices, the streamlining of the guidance process, and the inclusion of post-market elements in the negotiations. Regarding the proposal to develop a clinical investigator list, FDA noted that Industry submitted public comments to the CDRH Medical Device Innovation Initiative’s docket, which outline Industry’s point of view. Stakeholders also asked questions about optimizing the third party review process.  FDA provided an overview of what the third party review process entailed and described some overarching criteria under which a submission can be reviewed by a third party. FDA acknowledged the Agency is currently re-examining eligibility and trying to assess the appropriate implementation of this program.  FDA noted its intent was not to eliminate the program.  Stakeholder also inquired about the inclusion of a proposal on bundling and multiplex devices in the negotiations. FDA also addressed questions about streamlining the guidance process. Finally, FDA addressed stakeholders’ interests in post-market issues, and noted that the proposal package includes post-market components.

Laboratory Developed Tests (LDTs)
Stakeholders asked questions relating to LDTs. FDA explained why LDTs are currently under review by the Agency, and explained that LDTs are currently under enforcement discretion and are considered to be medical devices by FDA. Given that LDTs have expanded beyond what was considered appropriate when the enforcement discretion policy was originally implemented, and the potential public health impact of current LDTs, FDA is reconsidering its position on enforcement discretion.

Timing for Completing Negotiations
FDA and stakeholders discussed the timeline for completing negotiations.  FDA expressed its hope to reach an agreement by the end of June to facilitate meeting the statutory timeline governing the MDUFA reauthorization process. The Agency summarized the internal review process for clearance of any agreement that is reached (including review and approval by the FDA ratifiers, the Department of Health and Human Services, and the Office of Management and Budget), and described the statutory requirements to publish the FDA’s recommendations, to hold a public meeting on such recommendations, and to provide for a 30-day public comment period. FDA also noted that Congress has expressed its desire that FDA transmit the recommendations before the statutory deadline of January 15, 2012.


A stakeholder inquired whether a specific proposal made in the Prescription Drug User Fee Act (PDUFA) reauthorization negotiations might also be suitable in the MDUFA context. The proposal involves developing an enhanced structured approach to benefit-risk assessment and communication that would include a series of public workshops throughout PDUFA V for obtaining patient and other stakeholder perspectives to better establish the clinical context for assessing risk tolerance in certain therapeutic areas.

The stakeholder noted that getting timely access to safe and effective treatments is a key objective. However, depending on what diagnostics and treatments are available for any given medical condition, there often are differences of opinion (or tolerance) as to what constitutes safe and effective. The PDUFA proposal describes a process for seeking input from patients and stakeholders to further inform FDA’s consideration of risk-benefit tradeoffs.  FDA noted that the Agency is considering the applicability of this approach to devices.

No formal proposal was made, but stakeholders raised issues and concerns that would need to be carefully considered before using a similar model in the medical device area. Such issues and concerns included the following points and questions:

  • How would this work in the context of the 510(k) process?
  • Devices evolve at a faster pace than drugs.
  • Patients may be willing to lower the bar for use of a device beyond what would be advisable.
  • Certain patient populations are particularly vulnerable.
  • How to address the risk-benefit balance in “gray” areas, in which the disease condition is not life threatening
  • Inclusion of a clinician’s perspective

No formal proposal or concept was put forward by the stakeholder group at this time.

Schedule of Future Meetings

The next meeting will be held on June 16, 2011.

Meeting End Time: 3:30 PM

Page Last Updated: 07/16/2014
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