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Medical Devices

Minutes From Negotiation Meeting on MDUFA III Reauthorization, October 6, 2011

FDA - Industry MDUFA III Reauthorization Meeting
October 6, 2011, 9:20 - 12:30 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)
Toby Lowe CDRH
Thinh Nguyen OC
Tracy Phillips CDRH
Don St. Pierre CDRH
Francisco Vicenty CDRH
Ruth Watson Office of Legislation (OL)
Nicole Wolanski CDRH
Barbara Zimmerman CDRH
Hans Beinke Siemens (representing MITA)
David Fisher Medical Imaging Technology Alliance
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
Joseph Levitt Hogan Lovells US LLP (representing AdvaMed)
John Manthei Latham and Watkins (representing MDMA)
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: 9:20 am

Industry* provided a counter-proposal to the proposal offered by FDA on September 29, 2011.

Quantitative Goals

Industry proposed maintaining all MDUFA II goals throughout MDUFA III. Industry stated that this approach would minimize the disruption to the program. FDA explained several concerns with the current goal structure. The two-tiered PMA goals are not effective in helping FDA manage review times for those requiring Advisory Committee input. Additionally, there is a long delay between the Tier 1 and 2 goals, which does not incentivize reviewers to wrap up quickly upon missing the Tier 1 goal. Finally, the low percentage Tier 1 goal (i.e., 60%) is difficult to manage. For these reasons, FDA previously proposed separate, single tier goals for Original PMAs not requiring Advisory Committee review and Original PMAs requiring Advisory Committee review. FDA believes that restructuring the goals is an important step for improving performance and reducing review times. Industry asserted that the Tier 2 goals developed under MDUFA II were intended to be for PMAs that went to panel.

Industry also proposed adding a statement that FDA will not alter its current practice of allowing companies adequate time, including extensions to respond to Additional Information requests and Major Deficiency letters. Industry acknowledged that the Agency routinely grants extensions and would not like FDA to change this practice as a way to improve average total times for review times. Additionally, Industry proposed explicitly stating that Major Deficiency letters be based upon a complete review of the submission and include all deficiencies with the PMA. FDA explained that there are some circumstances where this is not an efficient way to complete the review. For example, labeling is often not reviewed in detail until major clinical issues are addressed. Industry acknowledged that labeling could be delayed, but other issues should be addressed earlier in the process.

Industry proposed goals for CLIA waiver application reviews, which were not included in MDUFA II. Industry also raised a concern that FDA’s previous proposal implied plans to take all CLIA waiver application reviews to Advisory Committees for review. FDA clarified that they plan to continue current practices, which result in very few CLIA waiver applications requiring Advisory Committee review.

FDA noted that the substantive interactions goals they initially proposed and Industry retained are new goals and reflect performance improvements. Industry noted that although the proposal includes quantitative measures for substantive interactions, the MDUFA II agreement envisioned the utilization of interactive review. FDA indicated they will require a transition phase and may not be met instantaneously. Consequently, their impact on the overall process may not be seen immediately.

Process Improvements

Industry proposed specific timelines relating to the Pre-Submission process. Industry also proposed that modifications to FDA’s feedback during pre-submissions be limited to situations in which FDA has concluded that the feedback does not adequately address important new issues materially affecting safety or effectiveness. FDA noted rare occasions in which they find something was missed that materially affects safety and effectiveness. Although the missed item may not be “new,” it cannot be ignored. Industry acknowledged this and suggested that FDA propose additional language. FDA and Industry agreed that pre-submission goals and the number of submissions to which the quantitative pre-submission goal applies may need to be reevaluated as part of the financial discussions, as the ability of the Agency to meet the timeframes proposed may be adversely affected if the number of pre-submission requests exceeds assumptions.

Industry proposed that FDA issue a guidance document prior to MDUFA III outlining proposed enhancements to the Third Party Review program. Discussion ensued on the timeframe for guidance publication and implementation as well as associated resource needs.

Industry noted that CDRH officials stated publicly the intent to execute their reorganization plan this year. FDA explained that they could begin implementation this fiscal year; however, full implementation would require additional resources to fill new management positions without reducing review capacity. Industry asked for the proposed plan; FDA indicated this information is not yet publicly available.

Industry proposed that the Reviewer Certification Program for CDRH reviewers be offered to third party reviewers. Industry also proposed that FDA publish the curriculum of this program and other course offerings and consider comments from stakeholders on the content for updated courses. Industry clarified that they are interested in general subject matters covered by training, such as course titles and brief descriptions but not individual course syllabi.

Industry proposed a specific timeframe for different phases of an independent assessment of the device review process, including publication and implementation of recommendations from the assessment. Industry clarified that appropriate quality systems standards that could be used in the assessment include: management responsibility, document controls and records management, and corrective and preventive action. Industry also proposed that the assessment include a nalysis of elements of the review process that consume or save time to facilitate a more efficient process.

Industry noted they view revised submission acceptance criteria as a core process improvement. FDA affirmed their plan to provide Industry with a list of objective criteria they plan to implement via guidance.

Industry provided a list of items they would like reported on regularly, noting that those related to performance should be reported quarterly and other items annually. Industry also requested that all CDRH reporting be broken down to the Division level. FDA noted that this request would result in very long quarterly reports and require substantial resources to implement. Both sides agreed to discuss this further.

Industry proposed that FDA update its website to reflect their review of previously published device guidance documents, including the deletion of guidance documents that are no longer in effect.

Regarding interactive review (IR), Industry proposed that reviewers share issues with applicants prior to incorporating them into a formal letter. Industry asserted that this was consistent with the discussions that occurred between FDA and industry during the MDUFA II negotiations on IR.

Shared Outcome Goals

Industry stated the importance of reducing total time and their appreciation that the sides were able to develop a set of shared total time goals.

Industry agreed with the definitions for 510(k) and PMA Total Time to Decision proposed by FDA and proposed a parallel definition for 180 Day PMA Supplement Total Time to Decision. These definitions use a trimmed mean to calculate 510(k) and 180 Day PMA Supplement performance and a trimmed mean of the three-year rolling average to calculate PMA performance.

Industry proposed revised Shared Outcome Goals for Total Time to Decision for 510(k)s, PMAs (aggregate expedited and non-expedited), and 180 Day PMA Supplements. The proposal includes average Total Time to Decision targets for the first year and calls for maintenance of the 180 Day PMA Supplement target and an annual 3% improvement for 510(k)s and PMAs thereafter. Additionally, in order to obtain performance data in a timely manner, Industry proposed closing cohorts when specific fixed high percentages are complete.

FDA noted that the goal for 3% annual improvement potentially penalizes success in the early years, as it would be more difficult to obtain such improvement every year if performance exceeds the goal in the initial years of MDUFA III. Industry explained that their goal is to see performance continue to trend in the right direction over the course of MDUFA III.

FDA indicated that the targets proposed were aggressive. There was substantial discussion as to how significant the impact of process improvements will be on total time to decision and when this impact will be seen. Industry asserted that the proposed pre-submission process will replace part of the time FDA currently spends reviewing marketing applications. FDA explained that time spent on pre-submissions is not time taken away from marketing applications. Therefore, pre-submissions will require additional work, even if there is benefit to applicants and the agency. Industry acknowledged the added workload and stated they are willing to pay a fee for pre-submissions. Industry also noted that enhancing refuse to file and refuse to accept would likely result in a reduction to FDA’s total average time to a final decision.

FDA noted that quantitative targets for total time are a huge risk given their lack of control over Industry’s portion of the total time. Additional discussion of the goal structure and specific targets is needed.

Next Steps

Both sides agreed that significant progress has been made regarding process improvements. FDA agreed to consider Industry’s comments from the discussion and provide a response and counter-proposal to their proposal.

Next Meeting

The next meeting will take place October 18, 2011.

Meeting End Time: 12:30 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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