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Medical Devices

Minutes From Negotiation Meeting on MDUFA III Reauthorization, September 29, 2011

FDA - Industry MDUFA III Reauthorization Meeting
September 29, 2011, 1:45 am - 6:00 pm
White Oak Bldg 1, Washington, DC
Room 4101 - 4105


To discuss MDUFA III reauthorization.


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)
Christy Foreman CDRH
Thinh Nguyen OC
Tracy Phillips CDRH
Ruth Watson Office of Legislation (OL)
Nicole Wolanski CDRH
Barbara Zimmerman CDRH
Hans Beinke Siemens (representing MITA)
David Fisher Medical Imaging Technology Alliance
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
David Mongillo American Clinical Laboratories Association
James Ruger Quest Diagnostics (representing ACLA)
Patricia Shrader Medtronic (representing AdvaMed)
Janet Trunzo Advanced Medical Technology Association

Meeting Start Time: 1:45 pm

The Agency responded to Industry’s* counter-proposal provided on September 13, 2011. The response focused on areas with the largest gaps between the Agency and Industry proposals. The Agency reiterated that the progress being made towards an agreement was constructive, but indicated their concerns about the schedule.

The Agency’s response proposed clarifications and limits to the Pre-Submission process, moving the performance goals from two tiers (in MDUFA II) to one tier, the need for a transition period, and the notion of shared outcome goals in addressing the quantitative metric for average total time.


The Agency’s proposal intends to address the details and timelines of the pre-submission process to assure consistency and predictability while balancing the strain on resources that would occur from the implementation of pre-submissions.

The Agency proposed that Pre-Submissions be defined as a request for feedback from the Agency on questions posed by the applicant, and that a Pre-Submission meeting be defined as a meeting or teleconference in which that feedback is provided. There was discussion with Industry with regards to whether the interaction would be limited to only the questions submitted by the applicant prior to the meeting. The Agency clarified that the intent was not to limit the interaction to only the questions provided, but to assure that the appropriate people are made available and for all participants to be prepared so that the meeting time is constructive. In addition, the Agency expects that the forthcoming Pre-Submissions guidance will include examples of questions that best elicit FDA’s feedback. As part of a Pre-Submission interaction, the Agency would provide feedback on protocols and additional requirements that need to be considered, but would not be commenting on issues that are relevant to an in depth review, such as data.

The Agency proposed that the meeting goal for scheduling the pre-submission meeting or teleconference be 60 days from receipt rather than the 45 days proposed by Industry, in order to allow time to coordinate schedules and for adequate review of the pre-submission. The Agency noted that this timeline does not mean that the meeting cannot happen prior to this if both parties are adequately prepared and the meeting schedules align. FDA also proposed that while all pre-submissions would be accepted and scheduled as quickly as possible, only the first 2000 pre-submissions would count towards the goal, citing the concern that higher numbers of Pre-Submissions would require a significant level of Agency resources. Industry stated that there may be a means of making additional resources available for pre-submissions by means of a pre-submission fee or other approach that would allow all submissions to be counted under the goal. The details of the meeting and the advice provided by the Agency would be documented in minutes that were approved by management and finalized within 45 days of the pre-submission meeting.

There was additional discussion with regards to the expectation that the Agency feedback provided to a Pre-Submission not subsequently change upon review of the formal IDE or marketing submission. The Agency raised the concern that the previously proposed language might limit the Agency’s flexibility to revisit the advice given when, subsequent to the meeting, issues materially affecting safety and effectiveness of the device needed to be communicated. This also includes the rare case when the Agency made an error in its initial assessment. The possibility of such occurrences should be minimized with improved management oversight through reduced reviewer-to-manager ratios, but in such instances the Agency needs to maintain its ability to protect public health.

Performance Goals

The Agency proposed establishing performance goals with a single tier performance metric rather than the two tiered metrics established in MDUFA II for all quantitative performance goals. The proposal divides PMAs that go to panel and those that do not into separate cohorts with different performance metrics. The Agency emphasized the importance of not managing to multiple tiers in order to provide more consistency and reliability in the program.

Industry expressed concerns with the single tier approach, specifically in regards to 510(k) submissions. Industry expressed concern that a higher percentage of submissions could fall outside of the performance metric since there was no second tier goal. The Agency indicated that a higher percentage would now fall under the single tier goal and, under the new proposal, the Agency would provide more visibility and interaction for those submissions that missed the performance goal.

Total Time

The Agency restated their concern with a total time performance metric that had no accountability on the time contributed by the applicant. The Agency proposed a shared outcome goal that appropriately acknowledged the role of both FDA and the applicant in reducing the total time to decision. The Agency shared its belief that the average total time is going to decrease based on the improvements proposed, but multiple factors could affect applicant response time, over which the Agency has limited control. The Agency proposed using FY2009 performance as a baseline for average total time and proposed a shared goal of a trend of improvement on that time throughout MDUFA III. The Agency indicated a reluctance to agree to a quantitative performance metric for total time without accountability on industry. Industry indicated its unwillingness to consider a total time goal with no established quantitative metric.

Process Improvements

Industry expressed concern that the Agency would change current practices to achieve a reduction in total time. The Agency explained that it did not intend to change its current practice with regard to applicant response time and extensions, but needed flexibility to implement process improvements that may be recommended by the proposed Independent Assessment.


The Agency discussed providing additional time for combination products due to the need for consultation with other centers and the complexity of the review, especially in the timeframes proposed for 510(k)s. Industry disagreed, and noted that a portion of combination products do not require cross-center consults.

The Agency stated the importance of acknowledging a transition period for implementation of these goals. There is significant effort in implementing the improvements mentioned that would require resources and organizational changes that would not be available prior to the start of MDUFA III.

FDA noted that it would not be able to implement Industry’s proposed program improvements for third party review without appropriate funding.

There was additional discussion around performance reporting. The Agency voiced concerns with the level of detail proposed by Industry and the resources required to generate those reports. Industry stated its willingness to discuss the level of reporting proposed in order to limit the burden on the Agency.

Next Meeting

The next meeting will take place October 6, 2011.

Meeting End Time: 6:00 pm

* For purposes of these minutes only, the term industry means AdvaMed, MITA, and MDMA and does not include ACLA unless specifically noted.

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