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Medical Devices

Minutes from Stakeholder Meeting on MDUFA III Reauthorization, November 17, 2011

Stakeholder Meeting on MDUFA III Reauthorization
November 17, 2011, 1:45 - 3:20 PM
HHS Humphrey Building, Washington, DC
Room 425A


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)
Sharon DavisCenter for Devices and Radiological Health (CDRH )
Elizabeth HillebrennerCDRH
Toby LoweCDRH
Arleen PinkosCDRH
Don St. PierreCDRH
Francisco VicentyCDRH
Ruth WatsonOffice of Legislation (OL)
Barbara ZimmermanCDRH
Paul BrownNational Research Center for Women & Families
Susan M. CampbellWomenHeart: The National Coalition for Women with Heart Disease
Eric GaschoNational Health Council
Suzanne HenryConsumers Union
Campbell HuttonJuvenile Diabetes Research Foundation
Lisa McGiffertConsumers Union
Heidi MolineUnion of Concerned Scientists
Martha NolanSociety for Women’s Health Research
Lisa SwirskyConsumers Union
Cindy TomlinsonAmerican Society for Radiation Oncology
Additional Registered Stakeholders
Cynthia BensAlliance for Aging Research
Diane Edquist DormanNational Organization for Rare Disorders
Lane KeetonTruth in Medicine Incorporated
Jenny LiljebergAmerican Society of Cataract and Refractive Surgery
Rebecca O’ConnorParkinson’s Action Network
Kate RyanNational Women’s Health Network

Meeting Start Time: 1:45 PM

Update on Negotiations

FDA reviewed the status of negotiations with Industry. At this time, there is substantial agreement on an overall program; however, it is subject to change as ongoing discussions address financial aspects of the program.

FDA provided a recap of events leading to this point in the reauthorization process. From January through April, FDA presented an extensive analysis of the device review program which prompted robust discussions of areas for improvement. On April 13 th and May 4th, FDA presented a comprehensive proposal and cost estimate. On June 1 st, Industry responded with a counter-proposal for a two year extension of MDUFA II. FDA could not support Industry’s two year proposal and asked them to provide a detailed description of what they want in a five-year program. Industry responded with a detailed proposal on July 26 th that included goals for total time to decision. This led to a sequence of proposal exchanges from August through October, resulting in substantial agreement on most elements of a draft Commitment Letter. On October 31 st and November 1 st, FDA presented an estimate of the resources needed to achieve the draft Commitment Letter and explained its basis. In response to Industry’s concerns with cost, FDA provided a revised proposal on November 10 th with some changes to the draft Commitment Letter that lowered the cost. Discussions of resources are ongoing.

FDA described key features of the draft Commitment Letter. It includes new product development goals, which provide a more structured approach compared to the current pre-IDE process to clarify product-specific requirements for IDEs, 510(k)s and PMAs prior to submission of an application. Applicants would pay fees for “pre-submissions” through which FDA would respond in writing within a specified time. If a meeting is necessary, it would be held shortly thereafter and the meeting minutes finalized within a specified time. This process is intended to provide Industry with greater predictability regarding submission requirements and timeliness. The issue of how to address uncertainty regarding the expected quantity of pre-submissions per year will need to be resolved during financial discussions.

In terms of quantitative FDA review day goals, FDA finds the current two-tier structure difficult to manage. Furthermore, it results in bunching of submissions at both goals. FDA therefore proposed to simplify the program by implementing single tier goals with a high degree of assurance. If such a goal is missed and review is not completed shortly thereafter, FDA would communicate with the applicant a plan for resolving remaining issues. One goal of this structure is to incentivize complete reviews within the timeline. It also provides more predictability, transparency, and accountability and is expected to help reduce total time to decision. FDA indicated they would need more staff to accomplish this.

Industry first introduced a concept of goals for total time to decision. As there are benefits to public health benefits in safe and effective devices reaching market quickly, FDA worked with Industry to develop a framework for considering total time to decision in a way that accounts for the shared responsibility of FDA and applicants. The current proposal includes “shared outcome goals” for average total time to decision that reflect improvement over the course of MDUFA III. FDA proposed to limit the impact of industry time (i.e., when a submission is on hold at FDA waiting for a response from the applicant) by using a “trimmed mean” that excludes extreme values. Industry proposed defining the cohort as “closed” when less than 100% of decisions are completed, to allow for the determination of goal attainment sooner.

The draft Commitment Letter also includes numerous qualitative goals: FDA would implement improved “Refuse to Accept” (RTA) and “Refuse to File” (RTF) checklists containing objective criteria for screening out 510(k) and PMA submissions that lack basic requirements; additional resources would be dedicated to improving the process for developing, tracking, and updating guidance documents; improvements would be made to the third party review program, if funded; additional resources would contribute to improvement of management training, a new reviewer certification program, and ensuring all reviewers are trained on new goals and how to manage them effectively; a consultant would conduct an independent evaluation of the device review process and make recommendations for improvements; FDA would then develop a corrective action and implementation plan which incorporates relevant findings into a Good Review Management Practices guidance; and FDA would provide additional granularity in quarterly performance reports to improve transparency and diagnostic value.

FDA has proposed several additional qualitative goals upon which agreement has not been reached. These include initiatives relating to benefit-risk determinations in medical device premarket review, assessment of risk tolerance, and use of Patient Representatives to provide patients’ views in the medical product development process.

Remaining issues include addressing uncertainties in financial assumptions (i.e., inflation, submission quantities, BA appropriations) and reaching agreement on the total fees and fee structure, which may require making adjustments to the draft Commitment Letter if the parties cannot reach agreement as to the resources needed under the current version of the Commitment Letter. FDA believes they are offering a package of program enhancements and improvements which have value in that they will reduce total time to decision, which is good for industry and public health. FDA hopes to find areas of agreement where Industry’s willingness to pay matches FDA’s capacity to perform.

FDA is required to prepare recommendations to Congress on reauthorization of the program, which will hopefully reflect an agreement with Industry based on resolution of the outstanding issues. FDA will seek clearance from HHS and OMB, brief Congressional committees, publish an FR Notice, open a docket for comments, and hold a public meeting. FDA will take all comments into consideration before transmitting the final, cleared package to Congress.


Stakeholders asked if FDA is negotiating with Industry on resources from Budget Authority (BA) appropriations or user fees. FDA stated that negotiations are regarding user fees, but that assumptions about BA are considered. At the present time, FDA does not anticipate BA will keep up with increasing costs and has reflected that in estimating resources needed from user fees. Stakeholders asked how this is handled in PDUFA. FDA explained that PDUFA includes inflation and workload adjustors, which help balance workload and resources. Additionally, a higher percentage of the prescription drug review program is paid for by user fees, so their exposure to BA shortfalls is lower. When asked, FDA further indicated that they have suggested adjustors for inflation and/or workload to address financial uncertainties in MDUFA III.

Stakeholders recalled previous statements by FDA that they often have to re-review submissions reviewed by Third Parties, and asked for additional details regarding FDA’s position on the program. FDA explained that the proposed improvements are intended to target problems with the quality of Third Party reviews through increased training and annual certification of Third Party reviewers, and increased management oversight of the overall program.

When asked about user fee structures, FDA stated their willingness to consider a broad range of structures that provides the total revenue needed to accomplish their commitments.

Stakeholders noted that the program appeared to focus on the process for clearing and approving devices. Stakeholders asked if user fees would also be used for postmarket or follow-up studies. FDA replied that the current draft Commitment Letter does not include provisions for additional postmarket activities funded by user fees; however, as defined in statute, the medical device review process includes the components of postmarket work that is related to premarket activities, such as post-approval studies.

Stakeholders asked if the proposed submission acceptance requirement of electronic copies will improve FDA’s ability to analyze sex, race, and other subpopulations. FDA explained that they are simply requesting electronic copies of submissions. While work is underway to improve clinical data standards for device trials, CDRH has not developed a standard data format such as that required by CDER, and which would allow for sorting of data based on subpopulations. This is not a part of current negotiations.

Meeting End Time: 3:20 PM

Page Last Updated: 07/16/2014
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