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Medical Devices

Minutes from Stakeholder Meeting on MDUFA III Reauthorization, June 16, 2011

Stakeholder Meeting on MDUFA III Reauthorization
June 16, 2011, 1:30 - 3:30 PM
HHS Humphrey Building, Washington, DC
Room 325A


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)
Ashley Boam 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
Elizabeth Hillebrenner CDRH
Toby Lowe CDRH
Michelle McMurry-Heath CDRH
Barbara Myklebust CDRH
Thinh Nguyen OC
Arleen Pinkos CDRH
Don St. Pierre CDRH
Ruth Watson Office of Legislation (OL)
Nicole Wolanski CDRH


Cynthia Bens Alliance for Aging Research
Paul Brown National Research Center for Women & Families
Eric Gascho National Health Council
Suzanne Henry Consumers Union
Mellanie True-Hills
Darby Hull Consumer Federation of America
Jeanie Kennedy American Academy of Orthopedic Surgeons
Heidi Moline Union of Concerned Scientists (UCS)
Martha Nolan Society for Women’s Health Research
Rebecca O’Connor Parkinson’s Action Group
Additional Registered Stakeholders
Cindy Tomlinson American Society for Radiation Oncology

Meeting Start Time: 1:40 pm


FDA acknowledged receiving the American Academy of Orthopedic Surgeons request for metrics from the pediatric device provisions in the last user fee bill and will address this at a later date.

FDA reviewed the status of negotiations with Industry, including the June 1, 2011 meeting with Industry. FDA answered questions from stakeholders regarding proposals made during the negotiations. FDA also answered questions regarding MDUFA II goals, the device review program, and the overall negotiation process and timeline.

Industry’s Proposal

Stakeholders asked questions pertaining to: Industry’s financial proposal, Industry’s expectations, the absence of a workload adjustment provision in MDUFA II, and ACLA’s proposal for laboratory developed tests (LDTs). Stakeholders asked about the fees in Industry’s two-year proposal. FDA explained that Industry based its fee proposal on an inflationary increase to fiscal year (FY) 2012 user fee collections, which will be lower than user fee spending in FY 2012 per the spending plan for MDUFA II, and which would result in a decline in FTEs funded by user fees. Stakeholders also asked about the proposed cut in appropriations by the House. FDA noted that early indications in the press suggest a 13-15% real impact after taking into account cost increases. In response to stakeholder questions, FDA clarified that Industry requested more timely scheduling of meetings and increased reviewer training as part of the two-year proposal. Stakeholders asked about the feasibility of maintaining the same goals with increased workload. FDA noted that the 510(k) program has been relatively stable historically, but that other types of submissions have been increasing; FDA explained that MDUFA II does not contain a workload adjustment factor as is contained in PDUFA. FDA clarified that a significant portion of the increased workload has come from pre-submissions, which are early interactions with Industry, and do not have fees or goals associated with them. With regard to LDTs, FDA explained the Agency’s intention to take a risk-based, phased-in approach regarding LDTs.


Stakeholders asked questions pertaining to the MDUFA II goals and also asked about total elapsed time to decision. FDA clarified that Industry does not dispute that FDA met the Tier 1 90% goal and the Tier 2 98% goal for 510(k)s, but that Industry is unhappy that the total elapsed time to decision (which includes Industry’s response time) has increased.

FDA’s Proposal

The state of overall negotiations was discussed. FDA clarified that Industry had not yet provided a substantive response to FDA’s proposals, and that the underlying issues being addressed in FDA’s proposals are not addressed in a timely manner by the Industry proposal for a two-year extension of the current program. FDA provided clarification on the post-market registry proposal, stating that the proposal would leverage MDEpiNet, a public private partnership, for device registry data.  The proposal could benefit companies that have submissions in particular device areas. 

Process and Timeline

Stakeholders asked questions regarding the negotiation process and timeline. In response to a stakeholder question about the impact of an agreement not being reached with Industry, FDA explained that user fees are just under 20% of the program; in contrast, fees are roughly 60% of the program under PDUFA. FDA explained that the negotiation process contemplates negotiating with Industry and attempting to reach agreement, publishing the Agency’s recommendations in the Federal Register, opening a docket for public input, holding a public meeting, and then finalizing the recommendations before transmitting the commitment letter to Congress.


Stakeholders expressed concern that a 2 year extension would separate MDUFA from PDUFA and create a new must-pass bill, which opens the program up to more statutory changes. Stakeholders also expressed concern about the time spent preparing and participating in negotiations and speculated that in two years, the political environment might be less supportive of a robust regulatory regime to ensure patient safety. Stakeholders expressed concern that a short-term extension might put MDUFA on a path similar to the Medicare sustainable growth rate (SGR), which is subject to an annual, one-year “doc fix” by Congress rather than resolving the problems with the SGR for the long term.

Stakeholders also indicated concern that resources would be shifted away from making safety a priority if FDA is held to specific standards without the resources necessary to meet those standards. FDA confirmed that FDA is not going to agree to any deal that would jeopardize safety and effectiveness, and that the regulatory reform agendas currently being discussed are of big concern to the FDA. The stakeholders expressed support for FDA’s commitment not to jeopardize patient safety.

Stakeholders expressed their view that uncertainties faced by FDA are potentially greater than those faced by Industry -- due to potential budget cuts and potential regulatory reform legislation. Stakeholders agreed that FDA is underfunded, but also acknowledged Industry’s perspective of not wanting to carry the additional user fee burden to make up for any reductions in Congressional appropriations, especially in a tight economic environment. Stakeholders noted that they perceived a divide between Industry and FDA that is larger than they had anticipated, and expressed surprise that Industry would propose only a two year extension.

Schedule of Future Meetings

The next meeting will be held on July 26, 2011.

Meeting End Time: 3:25 PM

Page Last Updated: 07/16/2014
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