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Medical Devices

Minutes from Stakeholder Meeting on MDUFA III Reauthorization, January 26, 2012

Stakeholder Meeting on MDUFA III Reauthorization
January 26, 2012, 1:30 – 3:00 PM


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


Malcolm BertoniOffice of the Commissioner (OC)
Ashley BoamCenter for Devices and Radiological Health (CDRH)
Nathan BrownOffice of Chief Counsel (OCC)
Kate CookCenter for Biologics Evaluation and Research (CBER)
Christy ForemanCDRH
Cynthia GarrisCDRH
Sheryl KochmanCenter for Biologics Evaluation and Research (CBER)
Toby LoweCDRH
Francisco VicentyCDRH
Ruth WatsonOffice of Legislation (OL)
Nicole WolanskiCDRH
Jason BarronNational Organization for Rare Disorders (NORD)
Cynthia BensAlliance for Aging Research
Catherine BoudreauxAmerican Association of Orthopaedic Surgeons
Pamela BradleyAmerican Association for Cancer Research
Paul BrownNational Research Center for Women & Families
Susan M. CampbellWomenHeart: The National Coalition for Women with Heart Disease
Campbell HuttonJuvenile Diabetes Research Foundation
Lisa McGiffertConsumers Union
Heidi MolineUnion of Concerned Scientists
Kate RyanNational Women’s Health Network
Leslie StevensSociety for Women’s Health Research (SWHR)
Lisa SwirskyConsumers Union
Cindy TomlinsonAmerican Society for Radiation Oncology
Diana ZuckermanNational Research Center for Women & Families

Meeting Start Time: 1:30 PM

Update on Negotiations

FDA reviewed the status of negotiations with Industry. FDA and Industry continue to meet regularly to try to reach agreement that balances commitments with resources Industry is willing to pay. The very large gap has been substantially narrowed and Industry has indicated the maximum range of funding they can support. Both parties are now working to revise the draft Commitment Letter to reflect a program FDA is comfortable achieving with the resources Industry can provide. Once that is established, the parties plan to discuss the fee structure.

FDA will follow all reauthorization steps outlined in the statute despite being significantly behind schedule. Specifically, FDA will obtain clearance from HHS and OMB, hold a 30 day public comment period and public meeting, and consider comments and make adjustments as necessary.


Stakeholders asked how negotiators have considered uncertainties regarding Budget Authority. FDA explained the appropriation trigger, which was established to ensure maintenance of Budget Authority for the Devices and Radiological Health program line of the FDA budget; however, FDA noted that increases to the Budget Authority appropriations for medical devices over time has led to a situation where the appropriation trigger is no longer serving its original purpose.

Stakeholders asked FDA to explain their estimation of resource needs. FDA indicated they took an analytical approach using a workload model developed by Booz Allen Hamiltion. The model uses current performance against existing goals to estimate the number of full time equivalents (FTEs) needed to meet proposed new goals. For practical reasons and to keep costs down, the Agency proposed a steady increase in staffing over 3 years accompanied by a ramp-up in performance goals.

Stakeholders asked if the planned quality assessment will include analysis of safety, noting their concern with the potential for increased safety issues with faster review times. FDA replied that the details of the assessment have not been worked out, but that the Agency plans to maintain review standards throughout the program.

Stakeholders noted the discrepancy between the current user fees and the overall cost of submission review. Given that user fees only cover a small portion of the overall cost, stakeholders asserted there is a dis-incentive for the Agency to review some devices under PMA versus 510(k). FDA stated that neither cost nor revenue is factored into determinations of regulatory pathway. Rather, FDA considers whether the device is already classified and its associated risks.

Stakeholders noted various legislative amendments currently under consideration by Congress that could impact the device program. Stakeholders expressed concern that CDRH is already under-funded and that any potential increase in workload from new legislative mandates, for example, requiring FDA to conduct more meetings with applicants or to impose other new procedures, could result in insufficient funding for post-market activities.

Stakeholders indicated concern with the focus on days in the quantitative performance goals, especially with respect to total time to decision goals. FDA explained that the average FDA review times are fairly stable and that the recent rise in total time to decision is due to the increased time manufacturers take to respond to questions. FDA believes this may be due to an increase in the average number of review cycles. Based on their analysis, FDA believes that inappropriate or unnecessary questions are a very small contributor but that the quality of incoming applications is a substantial contributor. To this end, FDA and Industry agreed upon objective submission acceptance criteria. The review clock will not begin until an acceptable submission is received. Stakeholders agreed that this proposal makes sense and should contribute to reducing the number of review cycles.

Stakeholders indicated their support for training and asked if user fees are included in the agreement for this purpose. FDA replied that the draft agreement does include some resources to improve training for new hires as well as increased professional development.

Stakeholders inquired as to the position of the American Clinical Laboratory Association (ACLA), which represents labs that produce Laboratory Developed Tests (LDTs). FDA indicated they continue to work toward an agreement that all parties, including ACLA, can support. FDA stated their position from the beginning of negotiations that any potential change in LDT policy would not have a major impact on workload during MDUFA III.

Stakeholders asked for additional information regarding proposed performance goals. FDA explained that the total number of goals is being reduced and simplified for easier management. For example, goals are now single-tiered and PMAs reviewed by an Advisory Committee are broken out into a separate cohort with a longer review time due to their complexity.

Stakeholders asked to what extent the submission review process is transparent to the public. FDA explained that, by law, applications are considered confidential until approved or cleared. In the case of positive decisions, FDA is attempting to increase transparency of what was reviewed. For example, FDA is currently piloting the posting of decision memos for 180 day PMA Supplements from two branches. Over the last two years, FDA has routinely asked for adequate summary information in 510(k) summaries provided by sponsors and posted them to FDA’s website upon clearance. OIVD also posts 510(k) decision summaries. In response to a stakeholder question, FDA confirmed that Advisory Committee meetings are public and that information presented in such forums are posted to FDA’s website.

Stakeholders asked FDA for estimates on the timing of a final agreement and clearance process. FDA indicated their hope that an agreement would be reached soon, but had no information with respect to specific timeframes.

Meeting End Time: 3:00 PM

Page Last Updated: 07/16/2014
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