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Medical Devices

Minutes from Stakeholder Meeting on MDUFA III Reauthorization, September 6, 2011

Stakeholder Meeting on MDUFA III Reauthorization
September 6, 2011, 1:30 - 3:30 PM
HHS Humphrey Building, Washington, DC
Room 325A


To provide a status update of the ongoing MDUFA III negotiations.


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)
Sharon Davis Center for Devices and Radiological Health (CDRH
Cindy Garris CDRH
Toby Lowe CDRH
Michelle McMurry-Heath CDRH
Barbara Myklebust CDRH
Arleen Pinkos CDRH
Ruth Watson Office of Legislation (OL)
Nicole Wolanski CDRH
Barbara Zimmerman CDRH
Paul Brown National Research Center for Women & Families
Susan M. Campbell WomenHeart: The National Coalition for Women with Heart Disease
Eric Gascho National Health Council
Suzanne Henry Consumers Union
Catherine Jeakle Hill American Association of Neurological Surgeons
Mellanie True-Hills
Joseph Isaacs United Spinal Association
Jeanie Kennedy American Academy of Orthopedic Surgeons
Martha Nolan Society for Women’s Health Research
Rebecca O’Connor Parkinson’s Action Network
Kate Ryan National Women’s Health Network
Andrew Sperling National Alliance on Mental Illness
Leslie Stevens Society for Women’s Health Research
Cindy Tomlinson American Society for Radiation Oncology
Additional Registered Stakeholders
Cynthia Bens Alliance for Aging Research
Diane Edquist Dorman National Organization for Rare Disorders
Darby Hull Consumer Federation of America
Jenny Liljeberg American Society of Cataract and Refractive Surgery
Erik Lontok American Association for Cancer Research
Heidi Moline Union of Concerned Scientists
Lisa Swirsky Consumers Union

Meeting Start Time: 1:45 PM

Update on Negotiations

FDA reviewed the status of negotiations with Industry. The Agency indicated the expectation was to receive a full response from Industry at the September 13, 2011 meeting. The Agency stated that the negotiations are at the point of working on the commitment letter and that all major proposal areas have now been identified. The Agency and Industry are working to narrow the focus and fashion an agreement that will have broad support among industry and other stakeholders.

The Agency explained that, once an agreement is reached, it will need to be cleared through the Administration and then will be published in the Federal Register so that all stakeholders can see the details. The Agency will hold a public meeting and accept comments during a 30 day comment period following the publication in the Federal Register. Following the public meeting and the comment period, FDA will review the comments and prepare the final recommendations to transmit to Congress.

In response to questions from the stakeholders, the Agency indicated that FDA is not going to publish any recommendations that fail to meet the Congressional expectation of a five-year reauthorization. Additionally, the Agency indicated that resource estimates had not been discussed in detail for any of the counter-proposals. A resource estimate was presented in early May for the Agency’s comprehensive proposal presented in April. Since then, the focus has been on discussing the technical details in counter-proposals from both sides, and then determining the resource estimate for the package once agreement is reached on the technical details.

FDA’s Counter-Proposal

On August 24, 2011 FDA offered a response and counter-proposal to Industry’s July 26, 2011 proposal. The Agency viewed its counter-proposal as responsive to Industry’s requests and objectives. The Agency indicated that it had designed the counter-proposal from the standpoint of how to improve predictability of submission requirements, quality of submissions, transparency of the review process, and consistency of review practices. The counter-proposal is predicated upon an adequately resourced premarket program. It included many of the same features as previously discussed, such as predictable early interactions, substantive interaction on a defined timeline, and interactive review, which would lead to marketing decisions in a predictable, reliable time frame. The Agency did include total time goals in response to Industry’s request for total time goals, although this would be a difficult change for the Agency. In order to manage the shared risk and shared responsibility, the Agency broke the total time goal into an applicant component and an Agency component. This would reduce the amount of time that an applicant has to respond to question from the Agency. The Agency’s proposal also simplified the goals to a single goal structure for each submission type, rather than the multiple tiers of goals currently in place.

Pre-submissions were discussed as a key feature of the Agency’s proposal. Industry has emphasized pre-submissions as an important feature for clarifying expectations up front so that applicants are clear on what should be in an application. The Agency raised as a possibility an annual product development fee which would be triggered by submission of a pre-submission or an Investigational Device Exemption (IDE) application. The Agency suggested the possibility of a discounted marketing application fee if the pre-submission pathway was used.

The Agency’s counter-proposal for CLIA waiver applications included timelines more in line with PMA timelines, as opposed to the 510(k) timelines proposed by Industry. Additionally, the Agency proposed an increase in time for each of the outlined goals for combination product submissions and companion diagnostics submissions. This is due to the complexity of these submissions and the need to involve staff outside of the Center.

The Agency proposed a number of process improvements, such as staff training and an independent assessment of review process management. The Agency also proposed increased granularity in quarterly performance reporting, in response to Industry’s requests. The Agency included a transition period in the proposal, to account for the need to bring on additional staff and train existing staff on the new goals prior to achieving the new performance levels.


In response to questions from stakeholders, the Agency indicated that specific resource needs associated with the recent proposals have not been discussed in detail. However, the Agency has estimated that, given the ambitiousness of total time goals and the addition of pre-submissions, the most recent proposal packages from both Industry and the Agency would be more expensive than the Agency’s original proposal presented in April.

Stakeholders asked about the prospects for getting recommendations to Congress by the January timeline. The Agency indicated that it is still working towards that goal, but that it will be very challenging.

Stakeholders expressed concern with making sure the Agency received adequate funding and increased staffing overall, not just in specific proposal areas like training. The Agency indicated that funding has not yet been determined, but that the Agency has to be realistic about what performance it can commit to based on the available funding. Stakeholders expressed concern about the third party review program, especially if Industry is proposing enhancements that would not be paid for by user fees.

Stakeholders expressed interest in incorporating postmarket safety assessments into premarket reviews, and applying user fee revenues to increase postmarket capacity and infrastructure. They noted concern that decreases in Budget Authority appropriations would lead to the reallocation of resources to achieve performance goals and would take staff and resources away from postmarket activities. Stakeholders provided examples from the pharmaceutical industry where issues were found through long term surveillance of a drug that would not have been found through premarket testing alone. Additionally, they pointed out that postmarket studies can analyze subpopulations that premarket studies may not be able to study. Stakeholders also indicated they see value in Unique Device Identifiers (UDI) as well as registries.

Meeting End Time: 3:15 PM

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