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Medical Devices

Minutes from Negotiation Meeting on MDUFA III Reauthorization, April 13, 2011

FDA – Industry MDUFA III Reauthorization Meeting
April 13, 2011, 10:00 – 4:30 pm
FDA White Oak Building 32, Silver Spring, MD
Room 4242


To discuss potential financial baselines for device process funding under MDUFA III, as well as discuss FDA’s proposal package.


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
Frank Claunts FDA Consultant
Christy Foreman CDRH
William Hubbard FDA Consultant
Elizabeth Hillebrenner CDRH
David Miller Office of Financial Management (OFM)
Daniel Montgomery CDRH
Thinh Nguyen OC
Tracy Phillips CDRH
Don St. Pierre CDRH
Ruth Watson Office of Legislation (OL)
Barbara Zimmerman CDRH
Susan Alpert Medtronic (representing AdvaMed)
Hans Beinke Siemens (representing MITA)
David Fisher Medical Imaging Technology Alliance (MITA)
John Ford Abbott Laboratories (representing AdvaMed)
Elisabeth George Phillips (representing MITA)
Donald Horton Laboratory Corporation of America Holdings (representing ACLA)
Tamima Itani Boston Scientific (representing MDMA)
Mark Leahey Medical Device Manufacturers Association (MDMA)
Joseph Levitt Hogan Lovells US LLP (representing AdvaMed)
John Manthei Latham and Watkins (representing MDMA)
David Mongillo American Clinical Laboratories Association (ACLA)
Jim Ruger Quest Diagnostics (representing ACLA)
Patricia Shrader Medtronic (representing AdvaMed)
Janet Trunzo Advanced Medical Technology Association (AdvaMed)

Meeting Start Time: 10:20 am


FDA opened by providing an overview of key factors that influenced the development of the proposal package. FDA noted that both FDA and Industry have endorsed the goal of “timely access to safe and effective devices while fostering innovation.” To achieve that goal, FDA identified key objectives (predictability, consistency, efficiency, and transparency), four categories of potential solutions (enhance capacity, manage workload, improve interaction, and foster innovation), and possible indicators of success. FDA also noted that achieving the desired program outcomes has been particularly challenging because they are a shared responsibility and not totally within FDA’s control. FDA also identified potential “dashboard” metrics to measure progress of the program, noting these metrics could be reported on an annual or quarterly basis to assess the state of the program more frequently.

FDA provided an overview of three possible financial baseline scenarios describing the cost of the current device review process and how different budget authority appropriation assumptions could affect the next Medical Device User Fee program (MDUFA III). These scenarios projected the cost of maintaining the current (FY 2010) level of work effort of 1,230 “fully-loaded” FDA full-time equivalent (FTE) staff over the five years of MDUFA III, assuming a steady 4% annual increase in costs. The “fully-loaded” rate is determined by dividing total FDA spending by the number of FTE staff. The baseline scenarios assumed that user fees would increase at the same 4% annual rate. The scenarios further assumed that user fees in 2013 would be 4% higher than FDA’s user fee expenditures in 2012 (which would represent a 17% increase from the 2012 authorized fee collection amount). FDA addressed three alternative scenarios for budget authority (BA) appropriations available for the device review process: a 4% annual increase in BA; a flat-lined 0% increase in BA; and 4% annual reduction in BA. With a 4% annual increase, FDA estimates that the current FTE levels could be maintained. In the flat BA scenario, a potential funding shortfall of $9.4 million in 2013 could result in a loss of 33 FTE; by 2017, the potential shortfall could rise to $51 million, resulting in a cumulative loss of 153 FTE. In the 4% BA reduction scenario, the funding shortfall could be $18.8 million in 2013, resulting in a loss of 66 FTE; by 2017, the shortfall could rise to $94.5 million, resulting in a cumulative loss of 284 FTE. FDA asserted that if these levels of reductions were to occur, the program would experience significant declines in performance.

FDA provided a list of program efficiencies that could be obtained with minimal additional expenditures, including: implementing a new “refuse to accept” (RTA) policy to objectively screen out incomplete submissions; making interactive review (IR) reporting mandatory; and emailing or faxing letters to allow sponsors to begin work on a response more quickly. FDA noted that while these initiatives are intended to streamline the program and reduce the agency’s workload in the long run, the adoption of these three initiatives would be challenging without additional investments in management capacity and systems. FDA stated that without additional program resources, the desired program outcomes of reduced time to final decision and reduced cycles per submission could not be achieved. Furthermore, the performance against current goals may not be sustainable if there are increases in workload, complexity, or if the RTA policy only has a minimal impact on the program. Under those circumstances, FDA noted that certain qualitative activities may decrease or take longer to complete, including development of guidance documents, review of pre-submissions and scheduling of pre-submission meetings, and/or FDA’s ability to interact “off the clock” (i.e., when an application is on hold).

At this point, the Agency provided a list of possible changes to the program. FDA believes these changes would lead to improvements in both overall review performance and the objectives of improved predictability, consistency, efficiency, and transparency, and would address the shared goal of providing timely access to safe and effective medical devices.

Improving Review Performance:

As previously noted, FDA is meeting most of the performance goals in MDUFA II, with a few notable exceptions pertaining to Expedited PMAs, Panel-track supplements, and the Tier 2 goal for Original and Panel-track PMA supplements. However, the average number of 510(k) review cycles and total average times to final decisions have been increasing, which are unintended program outcomes. FDA proposed changes to improve performance on the PMA goals and noted a willingness to increase the level of interaction between sponsors and the Agency. Other performance goals, not noted here, would remain unchanged. However, the sum total of the proposed improvements is intended to go beyond the performance goals and have a positive impact on program outcomes.

FDA proposed certain changes to the current PMA goals. For Expedited Original PMAs and Panel-Track Supplements, FDA proposed a single goal that would account for the need for Advisory Panel Review, while still providing a significant improvement over current performance. FDA also proposed making a distinction within the standard (non-expedited) PMA cohort. For Original PMAs and Panel-Track Supplements requiring a Panel Review, these submissions would have a single goal that accounts for the additional time required for the application to undergo Panel review, but that would result in faster review times compared to current performance. For Original PMAs and Panel Track Supplements not going to Panel, the goals would be revised to reflect the shorter review times possible when Panel review is not necessary. The new proposed structure is designed to provide better overall management control and incentives to reduce time to final decision.

For 510(k)s and PMAs, FDA proposed instituting an Interaction Goal in which it communicates issues identified during the review and/or a status update. Industry inquired what the anticipated impact might be to the pre-IDE/pre-Submission process. FDA noted that the new goals are intended to be additive and would require additional resources. These new performance goals are not intended to affect the pre-IDE/pre-Submission process.

FDA proposed additional steps that would improve performance and address predictability, consistency, efficiency, and transparency in other qualitative ways. Potential indicators of success could include decreases in the number of cycles per 510(k), decreases in total time to final decision, minimizing difference in performance between the highest and lowest performing branches, and reducing device development time and associated costs. These proposals were then described in more detail.

Enhance Capacity by Strengthening Scientific Infrastructure:

FDA highlighted the value of strengthening the program’s scientific infrastructure. As noted in previous discussions, CDRH faces challenges in maintaining an effective device review process in the face of a changing environment. The program currently has a higher turnover rate than other FDA medical product Centers, has insufficient mechanisms to retain experienced staff, has inadequate resources for continuing education, and continues to face gaps in expertise as well as insufficient depth of expertise in specific areas, such as biocompatibility and certain areas of clinical medicine. Further, the Center has a significant number of junior reviewers, who are often supervised by relatively new managers who must contend with a disproportionately high employee-to-supervisor ratio. Such circumstances can lead to challenges in providing adequate oversight, and lead to less consistency and predictability. FDA highlighted several proactive steps it has taken or is taking to strengthen its scientific infrastructure, including internal succession planning, establishment of the Center Science Council to help address cross-cutting scientific and clinical trials issues, and modifying the CDRH organizational structure to reduce the employee to supervisor ratio. FDA also noted that implementation of such a structure will be limited unless additional funding is available.

To address these infrastructure challenges, FDA proposed hiring review staff in targeted areas to eliminate current bottlenecks, establishing a cadre of experts in specific cross-cutting subject areas (e.g., software review), improving training and development, and expanding the new reviewer training program. For more seasoned reviewers, FDA proposed providing continuing education opportunities.

Enhance Capacity by Improving Review Management:

FDA proposed moving to a revised structure that would provide better review management oversight to help improve consistency. The restructuring would establish an employee-to-supervisor ratio of 10:1; the current ratio is 14:1 in ODE and 37:1 in OIVD (with a 16:1 ratio in Radiology). This structure would give Branch Chiefs more time to spend training new reviewers and providing supervisory technical and regulatory review for individual applications. In addition to the restructuring, FDA proposed developing and implementing a set of best practices in the review of applications. FDA would develop and publish guidance on Good Review Management Practices, as well as train people on these practices; periodic audits would be conducted to assess how well the program had been adopted.

Manage Workload – Submission Acceptance Criteria:

As noted in the March 7 th meeting, FDA receives a large number of incomplete submissions. Receipt of incomplete applications leads to multiple cycles and longer review times, and diverts resources from the review of complete submissions. Industry noted its disagreement with how FDA defined the quality of a submission. FDA stated it hoped to address any ambiguity about submission quality by clearly defining in guidance objective criteria for what constitutes a complete submission. For example, FDA found that critical information needed to facilitate timely review of PMAs was often missing, including statistical analysis (e.g., SAS) datasets, patient line listing and test reports. As a result of these missing pieces, reviewers and/or consultants have been unable to initiate their portions of the review until the respective missing pieces are provided. In order to address this issue, FDA proposed to implement revised checklists for “refuse to accept” (for IDEs and 510(k)s) and to add an administrative “refuse to accept” checklist to the current “refuse to file” criteria (for PMAs) and update relevant guidance documents accordingly. FDA described what elements these checklists might include for 510(k)s, PMAs, and IDEs. For all submission types, FDA proposed requiring an electronic “eCopy” of the submission and having the sponsor note any prior interactions with the Agency relating to that submission. FDA also noted that IDEs that are not accepted will be automatically converted to a Pre-IDE submission. When asked if FDA was requiring an interaction prior to IDE submission, FDA clarified that the intent is not to require an interaction, but to assist sponsors who are unfamiliar with IDE process. FDA noted some illustrative examples of unacceptable submissions that have been received by FDA. FDA believes it is important to have an interaction with the sponsor to assist in addressing the critical issues that would lead to IDE approval and initiation of the clinical study.

Manage Workload – Increase Efficiency of the Guidance Process:

During the course of these negotiations, both sides have commented on the importance of having guidance documents available. FDA described how guidance documents benefit both industry and FDA. These documents provide more predictability, particularly when the sponsor knows the guidance is up-to-date. When guidance is followed, FDA receives higher quality submissions and time to market for the product is often shorter. Data in the 510(k) Report suggests that 510(k)s with device-specific guidance tend to be reviewed more efficiently and quickly.

FDA believes it can further improve the guidance process. It proposed to add a senior level manager to provide oversight to the premarket guidance process. It would also revise and implement procedures that will produce guidance documents in a more timely manner. FDA would increase capacity for development of more timely guidance, as well as increase capacity to support more timely updates of current guidances. FDA would periodically (i.e., every 5 years) assess guidance documents to determine if they require technical updates, such as minor clarifications or revisions regarding certain recommendations, to ensure that FDA’s latest thinking is appropriately reflected in guidance; more substantive revisions would follow the regular guidance development process. Industry suggested considering an implementation period when issuing these technical updates. Finally, FDA proposed establishing a tracking system for guidance documents moving through the development pipeline.

Manage Workload – Improving consistency and predictability of PMA review:

Earlier in the day, FDA outlined potential new PMA goals and the reasons for proposing changes to the PMA-related performance goals. In the afternoon, FDA and Industry further discussed some of the challenges posed by various PMA submissions and some of the reasons for proposing revised goals.

At one point, industry noted that the list of proposals seemed to underrepresent the importance of the 510(k) program. In response, FDA outlined improvements being proposed that should improve the 510(k) program. FDA explained that good review management practices apply to all products, not just PMAs. FDA noted that an additional interaction goal was being proposed for 510(k)s -- sending an additional information letter or a significant communication to the sponsor by day 60. This should facilitate getting to a final decision sooner. FDA also noted that the revised “refuse to accept” policy should improve efficiency, while also noting the need to develop clear and objective criteria for that policy. Additionally, the organizational restructuring should address the issue of better oversight and consistency over all product areas. Finally, the device-specific guidances would address issues for many devices falling under the 510(k) program.

Manage Workload – Level the Playing Field for Submissions: Bundling and Multiplex Devices

FDA raised concerns about the contribution of bundling and multiplex devices to the current workload. Bundling refers to the inclusion of multiple devices or multiple indications for use for a device in a single premarket submission, including products subject to the device and biologics license application (BLA) authorities, for purposes of review and user fees. Bundling can also occur when the same change is made to devices approved under multiple PMAs. In these negotiations, the points raised refer to only the submissions of multiple devices in a single submission. FDA emphasized that in certain cases, bundling is necessary and appropriate to review multiple devices together. However, in doing so, bundled submissions, as well as multiplexed devices (which are distinct from bundled devices), pose challenges during the review process and require more resources. Bundled submissions and multiplex devices can now be much larger than originally anticipated, and as a result, they can slow the review of other submissions.

In response to these challenges, FDA raised several proposals to level the playing field. First, it would modify the existing guidance to better clarify the Agency’s thinking on bundling. The second proposal addressed revising either the fee structure, the performance goal, or both to account for additional effort required to review bundled 510(k) submissions and multiplex devices.

Improving Interactions:

FDA believes that interactions with sponsors can be improved. FDA proposed making mandatory the tracking of Interactive Review (IR). It would also identify best practices and incorporate them into the Good Review Management Practices guidance and would establish Interaction Goals for 510(k)s and PMAs. FDA further clarified why it was mandating the tracking of IR, rather than mandating the use of IR. FDA wants to support the use of IR, but noted there are instances where it is not needed or the problems with the submission are better communicated through an additional information or major deficiency letter. In general, FDA wants to encourage the use of IR when it can result in fewer review cycles and/or a shorter time to final decision, rather than mandating use of IR in all instances. The best practices in the guidance would provide criteria by which one could monitor and track the use of IR. FDA also noted that with the current management structure it was difficult to provide proper oversight of this process.

In addition to enhancing the IR process, FDA proposed holding yearly public meetings, along the lines of the OIVD Roundtables, with stakeholders at the division (device-specific) level.

Fostering Innovation:

FDA presented several proposals to foster innovation.

The first proposal addressed improving U.S. clinical trial infrastructure. FDA described challenges in conducting clinical trials in the U.S. FDA proposed to develop and share publicly a clinical investigator list. Industry noted that this proposal may have some unintended consequences if there is not accompanying guidance to outline how it should be used. Industry expressed concerns that such a list could adversely impact the medical device community’s ability to conduct clinical studies, if used inappropriately.

FDA proposed making permanent and expanding a training program for clinical investigators. This proposal is based on a current pilot program tested last year at several academic research centers. FDA Bioresearch Monitoring staff and certain device experts would conduct a full day of training for current clinical investigators, newly trained physicians, IRB members, and study management staff. This program is intended to better educate clinical investigators and to encourage participation in clinical research by newly trained physicians; the program was well-received at all three academic research centers last year.

FDA also proposed developing and implementing a certification program for clinical research sites. The program would allow for partnering with independent accrediting organizations to train and certify/accredit various parts of an institution’s clinical research infrastructure. FDA noted this program was different from the proposal currently outlined in the Innovation White Paper.

The final proposal related to clinical trial registries. FDA noted that the patient and consumer advocacy stakeholders had expressed support for better post-approval information. Under this proposal, when FDA mandates a post-approval study, there would be infrastructure in place to try to nest the study within an existing registry, leading to reduced cost for the manufacturer and faster initiation of the post-approval study.


In response to the Agency’s list of proposals, industry noted that without knowing the full cost of the proposals, they could not express approval or disapproval. FDA stated it was unable to provide that information during the meeting, and expressed the desire to receive at least preliminary feedback from Industry and any proposals that Industry has, and to incorporate both into the proposal package and cost estimate.

Another issue raised during the discussion was Industry’s concerns about predictability. Industry noted these negotiations were happening in the midst of potentially major changes -- in particular, the internal changes to the 510(k) program and the pending IOM report. FDA noted Industry’s concerns and emphasized that FDA was conducting its review of the 510(k) program with a high degree of transparency related to the 510(k) program changes than any other program in the past.

Finally, Industry recommended waiting to establish working groups until there was more information about the proposals, including cost data.

FDA acknowledged Industry’s feedback and agreed that the next step was to refine the proposal package and determine an estimate of costs. Industry agreed to provide feedback to FDA before the next meeting to facilitate refinement of the proposal package and estimation of costs. FDA stated that it plans to provide cost estimates of the refined package at the next meeting.

Next Meeting

The next meeting will take place May 4, 2011.

Meeting End Time: 4:40 pm

Page Last Updated: 07/16/2014
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