FDA – Industry MDUFA III Reauthorization Meeting

August 24, 2011, 1:00 – 5:00 pm

FDA Switzer Building, Washington, DC

Room 1007


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
Bill Hubbard FDA Consultant
Toby Lowe CDRH
Thinh Nguyen CDRH
Tracy Phillips CDRH
Don St. Pierre CDRH
Ruth Watson Office of Legislation (OL)
Nicole Wolanski CDRH
Barbara Zimmerman CDRH
Susan Alpert Medtronic (representing AdvaMed)
Brian Connell 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
John Manthei Latham and Watkins (representing MDMA)
David Mongillo American Clinical Laboratories Association
Patricia Shrader Medtronic (representing AdvaMed)
Janet Trunzo Advanced Medical Technology Association

Meeting Start Time: 1:15 pm

The Agency provided a response and counter-proposal to Industry’s * July 26, 2011 proposal that the Agency viewed as being responsive to Industry’s requests and objectives. The Agency indicated its goal of achieving several objectives that are held in common with Industry: predictability of submission requirements, improved quality of submissions, transparency during the review of submissions, predictability of decision timelines, consistency of review practices, and an adequately resourced premarket program.

The Agency presented a counter-proposal that included predictable early interactions, substantive interaction on a defined timeline, interactive review, and which would lead to marketing decisions in a predictable, reliable time frame. The Agency proposal incorporates total time goals in response to Industry’s July 26 proposal. The Agency indicated that there are significant concerns about this approach within the Agency and within the larger stakeholder community, but expressed FDA’s willingness to work towards an acceptable approach for total time goals because this particular element is important to Industry.

The Agency’s counter-proposal centered around a more simplified goal structure, which would be easier to implement and improve predictability of the program, leaving the program less prone to unintended consequences. The Agency also included other aspects that Industry had requested, such as greater transparency and increased granularity in reporting. The simpler goal structure includes a single, high percentage, goal for each performance metric, rather than the tiered approach used in previous MDUFA programs and in Industry’s proposal. This provides more clarity to industry so applicants will know when they will receive feedback from the Agency on their marketing submissions, and allows the Agency’s review staff to better manage their time. This structure also allows more flexibility in the Agency’s management strategy, allowing for adjustments as needed to ensure achievement of the desired outcomes--specifically, reducing review cycles and reducing total time to decision.

The Agency’s performance goal proposal included a defined total time goal for each submission type, with a portion of that time allotted to the Agency for review of the submission and a portion allotted to the applicant to respond to feedback from the Agency. In FDA’s view, this approach, in which time is apportioned to both the Agency and the applicant, is critical given the shared responsibility for and control over meeting total time goals and reducing total time to decision. The Agency also proposed specified milestones for interactions with the applicant, which will allow the applicant to have a clear understanding of their submission status and the likely timing of a marketing decision.

The Agency also proposed process improvements, such as a structured pre-submission process. The pre-submission process is intended to clarify FDA expectations for a forthcoming IDE or marketing application, improve predictability and transparency, reduce subsequent review time, and provide a link between marketing applications and prior interactions with the Agency. The Agency proposed 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 a discounted marketing application fee if the pre-submission pathway was used.

The Agency and Industry agreed that further discussions would be needed to address the Agency’s concerns about its ability to meet performance goals if faced with decreased resources due to reductions or insufficient increases in budget authority.

The Agency presented draft commitment letter language with the details of the proposal.


The Agency’s pre-submission proposal featured goals for scheduling a meeting or teleconference within 60 days of receipt of a complete pre-submission package. Additionally, the Agency would provide initial feedback to the applicant prior to the meeting, and meeting minutes would be finalized within a set time following the meeting. The Agency would commit to a certain number of meetings and teleconferences per year according to these goals. Additional pre-submission meetings in a given year would still be honored and would be scheduled as quickly as resources permit, and hopefully in the specified timelines, but would not be subject to the goals. Likewise, the goals would only apply to the first pre-submission meeting request from an applicant for a specific device. Subsequent meetings for the same device would not be subject to the goals, although the Agency would strive to meet the same timelines.

Discussion with Industry on this topic included confirmation that the number of meetings and teleconferences that the Agency would commit to scheduling within the proposed goals is intended to leave room for the Agency’s current pre-submission workload to grow; the current number of such meetings is considerably below the proposed number that would be subject to scheduling goals. The Agency explained that applying the goal to a certain number of meetings is designed to ensure that the goal is consistent with resources available for scheduling and preparing for meetings.

The Agency would also publish a guidance document regarding pre-submissions, including criteria for handling situations where the Agency’s thinking has changed since the advice given during a pre-submission meeting, such as circumstances when new scientific information is available or a public health issue exists. In such cases, managerial oversight would be required to communicate modified recommendations to the applicant.

Submission Performance Goals

The Agency proposed a single high-percentage goal for each performance metric. The proposal included a similar structure for each submission type: 1) a planned Initial Interaction to communicate the name of the reviewer and the acceptance of the submission for further review after an assessment against objective acceptance criteria; 2) a planned Substantive Interaction to communicate with the applicant at the point when the reviewer has completed a substantive review of the submission (this could be a formal deficiency letter, a “telephone hold,” or a status email explaining that no hold is needed); 3) Interactive Review immediately following the Substantive Interaction if no hold is required or following receipt of a response to questions posed in the Substantive Interaction if a hold is required; and 4) a Total Time goal in which a marketing decision would be provided to the applicant. The Total Time structure would allot a specific number of days to the Agency for an initial internal review and Interactive Review with the applicant, and a specific number of days for Industry to respond to questions posed in a Substantive Interaction when a hold was required. The proposed structure would allow for a single hold for each submission.

If the Agency does not complete our review within the allotted days, the goal would be considered not to be met for that submission. If the applicant does not respond within their allotted days following a hold, their submission would be considered withdrawn; this policy would be consistent with current regulations, as the Agency currently grants extensions of time to applicants beyond the time limits in the regulations. Industry expressed concern with the reduction in time allowed for applicants to respond to questions. The Agency explained that there is no way to manage to a Total Time goal if there is not accountability on both parties, which for the applicant would be the need to respond quickly. As an example, for PMAs, applicants currently have 180 days to respond when their submission is put on hold. If requested, the applicant may be granted an additional 180 days to respond, which could result in 360 days just in industry time alone; if the Agency is subject to a total time goal, then it could not grant extensions to applicants that would leave the Agency little or no time to complete the application within the allotted total days. The Agency intends that pre-submission interactions and guidance documents will help applicants submit higher quality applications and reduce the need for long response times during a review, and emphasized that in order to manage to a Total Time goal and see a reduction in overall time to decision, applicants will need to respond within shorter timeframes than they are currently.

There was additional discussion about the definition of an FDA Decision for 510(k) submissions. Historically, certain decisions, such as withdrawals, were not considered MDUFA decisions for goal performance reporting for 510(k)s, although they were added for PMAs under MDUFA II. The Agency’s proposal includes all 510(k)s for which a fee was paid in goal performance reporting, regardless of the final decision. Industry objected to this proposal, indicating their desire to only count SE and NSE decisions for goal performance reporting. The Agency explained that review staff can spend a significant amount of time on a submission that ultimately gets withdrawn because the applicant does not respond to deficiencies. The Agency believes the outcomes of these submissions should be included in goal performance reporting to fully reflect the Agency’s overall performance. Additionally, the Agency believes that withdrawn submissions need to be included in the context of shared responsibility in a Total Time goal structure.

The Agency’s proposal included a high percentage metric for each cohort. Industry expressed concern about the remaining submissions that did not meet the single goal. The Agency explained that the intention would be to manage toward completion of those submissions as close to the missed goal as possible, rather than letting those submissions linger. Industry stated that the purpose of the Tier 2 goal under MDUFA II was to ensure that submissions were not ignored once the initial goal was missed. FDA stated that quarterly reports would highlight submissions that missed goals, reporting on the total number of elapsed days for each open submission each quarter until the submission was completed. Initial Interaction and Substantive Interaction goals are also intended to shift the distribution of decision times “to the left;” that is, shortening decision times across the board, which would prevent the current phenomenon of submissions clustering around the deadline.

Industry expressed concern with Interactive Review being reserved until after a hold. The Agency explained that Interactive Review would be at the reviewer’s discretion prior to the Substantive Interaction in order to allow the reviewer to manage the review as needed. Additionally, the Agency noted that Industry has been asking for more managerial supervision and consistency between reviewers. In order to achieve this, substantive questions need to go through the Branch Chief prior to being sent to the applicant. It is more efficient for the Branch Chiefs to ensure consistency by reviewing a complete review memo reflecting all of the deficiencies, which are then sent in a single Substantive Interaction, rather than for the Branch Chief to review individual deficiencies to be separately relayed to the applicant.

The Agency indicated that there are some potential adverse consequences of the Total Time approach. NSE decisions for lack of performance data may increase, at least initially. The Agency also anticipates an increase in appeals. Since the time for applicants to respond will be reduced, the number of withdrawn submissions may increase, which would have the potential to also increase the number of total submissions to the extent those applicants resubmit. The Agency does not expect a transition to a total time program to be simple. It would take significant work, training, and education on both the Agency side and industry side to have a successful program based on this approach.

The Agency’s proposal included performance goals for CLIA Waiver applications. Industry expressed concern that the timelines were consistent with PMA review times rather than 510(k) review times. The Agency explained that the clinical data to support a CLIA Waiver is more similar to a PMA. Additionally, goals were designed to be achievable without the application of additional resources in order to remain consistent with the CLIA statute.

The Agency’s proposal provided for an increase in time of 25% for each of the outlined goals for combination product submissions and companion diagnostic submissions. These submissions are complex and involve staff outside of the Center, which strains the Agency’s ability to meet performance goals. The 25% increase in days would be applied both to Agency time and the applicant’s time. For all performance goals, the Agency proposed that the goals will only apply for annual cohorts with more than ten submissions of each type.

Process Improvements

The Agency’s proposal would apply user fee revenue to enhance scientific review capacity, reduce the ratio of review staff to supervisors, conduct additional training, and develop targeted retention bonuses to address attrition of review staff. The proposal would apply user fee revenue to management training and review staff training, including a MDUFA III training program and a reviewer certification program, including publishing the curriculum of the certification program and accepting comments from stakeholders. The Agency would commit to two Vendor Days each year. The Agency proposed to reauthorize the third party review program.

The Agency proposed an independent assessment of review process management to be conducted by a private, independent consulting firm. This would analyze various areas of the review program such as root causes for decision delays, best practices, and resources. The Agency proposed that the assessment would consider efficiency issues in both the Agency’s operations and the input to the review system, submissions from industry. Industry expressed concern with the idea that the assessment would also look at Industry inputs to the system. FDA clarified that the proposed assessment would focus on submissions and their role in the device review process, and was not intended to suggest an invasive review of companies.

The Agency proposed to publish a guidance document outlining objective criteria for revised “refuse to accept/refuse to file” checklists. Industry requested to further discuss the criteria being considered.

The Agency proposed more detailed performance reporting, increasing the granularity of the data per Industry’s request. The Agency believes that an increased spotlight on performance and missed goals will lead to fewer missed goals and heightened ability to analyze issues in the review process and implement improvements. The Agency proposed to use user fee revenue to improve the guidance document process, including increasing resources dedicated to the process, and posting a list of prioritized guidance documents for stakeholder comment.

The Agency’s proposal included a transition period in order to allow for successful implementation including increasing staffing, training, and putting new systems in place.

The Agency indicated that they had not yet completed a detailed cost analysis of the proposal, indicating that the proposal was developed in response to what Industry had requested and that it is more efficient to work towards agreement on the features of the program and then determine the cost once Industry and the Agency were in agreement. Additionally, the Agency indicated that it will be difficult to determine accurate cost assessments given the significant changes to the program if we move to a Total Time structure. The Agency believes that a Total Time goal structure could lead to more withdrawals and the effect on the overall volume of submission would need to be considered when estimating the costs of the new program.

Industry agreed to bring their initial response on August 31, 2011.

Next Meeting

The next meeting will take place August 31, 2011.

Meeting End Time: 5:05 pm

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