FDA - Industry MDUFA III Reauthorization Meeting

October 26, 2011, 10:30 - 12:15 pm

FDA White Oak Building, Silver Spring, MD

Room 2102


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
Elizabeth Hillebrenner CDRH
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
Susan Alpert Medtronic (representing AdvaMed)
David Fisher Medical Imaging Technology Alliance
John Ford Abbott Laboratories (representing AdvaMed)
Tamima Itani Boston Scientific (representing MDMA)
Mark Leahey Medical Device Manufacturers Association
Joseph Levitt Hogan Lovells US LLP (representing AdvaMed)
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: 10:30 am

Industry 1 provided initial feedback on the proposal offered by FDA on October 21, 2011 and noted their plan to provide a counter-proposal on October 31, 2011.

Industry stated that they are encouraged by the progress being made, which they attribute to willingness of both sides to listen to feedback from each other. Industry noted examples of areas where each side has compromised: While Industry preferred two-tier goals, they agree to single tier goals as FDA indicated this structure will be more manageable and consequently more successful. Although FDA is concerned with risks associated with goals for total time to decision, they have worked with Industry to develop a feasible shared total time goal structure. Industry stated that the number of outstanding issues is shrinking and indicated that both sides want to see a successful program under MDUFA III.

Industry indicated that the counter-proposal they will provide on Monday will include revised numbers associated with quantitative FDA time goals, but no changes to the goal structure. Industry agrees with the goal framework, which calls for progressive improvement over the first three years to reach targets, but Industry indicated that they may need to be modified to meet Industry’s expectations for continuous positive improvement in all submission types. FDA explained that their proposal reflects consideration of the whole system, including areas Industry indicated were most important and the degree of improvements that can be feasibly implemented in the first year.

Industry asked clarifying questions regarding FDA’s proposal for average total time to decision goals. Industry specifically requested data on current performance against these goals using the agreed upon definitions. FDA provided some data, noting the following limitations: reviews have not been managed towards these goals as they were not a part of MDUFA II; the most recent cohorts are not closed; data on PMAs are highly variable given the small sample size; and small discrepancies in different data sources exist due to technicalities such as differences in dates of payment and submission. FDA explained two methods with similar results for estimating FY 2009 510(k) performance while the cohort is incomplete. Industry indicated that establishment of baseline performance is essential in order to benchmark improvements through the progressive goal structure.

FDA noted that, following Industry’s stated concerns on October 21, 2011, they agree to omit a separate goal for 510(k)s for those combination products and companion diagnostics that require consulting review from another Center. Instead, these submissions would remain part of the entire 510(k) cohort, as is current practice.

Based on Industry’s previous feedback, FDA also proposed revisions to their October 21, 2011 proposal for the impact of unsolicited major amendments on the review clock. Specifically, FDA proposed that submission of an unsolicited major amendment prior to the Substantive Interaction extends the FDA Day review clock by the number of FDA Days that have elapsed. Submission of an unsolicited major amendment after the Substantive Interaction extends the FDA Day goal by the number of FDA Days equal to 75% of the difference between the filing date and the date of receipt of the amendment. FDA explained that this proposal is intended to incentivize applicants to send complete submissions up front and facilitate an efficient and complete review by FDA prior to the substantive interaction.

Industry questioned the rationale for FDA’s proposed timeline for providing written feedback on PMAs requiring Advisory Committee review which miss the goal. FDA explained that the same time period was proposed for all PMAs missing the goal, to allow for a consistent management approach. Industry pointed out that this cohort already has a separate review goal, and requested that FDA reconsider this timeframe.

There was a discussion of quarterly and annual reporting commitments. FDA indicated they did not agree to Industry’s request for reporting of NSE and withdrawal rates at the Division level, but only at the aggregate Center level. FDA noted that publication of Division-level NSE rates could result in inappropriate inferences to which FDA could not respond, given that NSE decisions are not public. Because the user fee program is about performance, FDA agreed to report performance data at the Division level per Industry’s request.

ACLA restated their position and proposal. Specifically, ACLA believes clinical labs differ from device manufacturers, and laboratory developed tests (LDTs) differ from medical devices. ACLA also stated that lifting enforcement discretion on LDTs would have an unknown but potentially significant impact on workload and consequently on performance against goals and fee revenues. ACLA proposed that clinical labs and LDTs be exempt from MDUFA III, except for clinical labs which develop a device for sale through interstate commerce. FDA acknowledged ACLA’s proposal and noted that the pending guidance documents which would outline FDA’s planned approach to regulation of LDTs are not likely to be published in time for their consideration in MDUFA III negotiations. FDA has publicly stated that, should enforcement discretion for LDTs be lifted, FDA would implement a risk-based, phased-in approach to their regulation. Therefore, any potential impact on workload during MDUFA III would be minimal.  

Industry stated that, aside from concerns with the numbers associated with quantitative goals outlined above, no further substantive issues remain for the Commitment Letter.

Next Steps

Industry will provide a specific counter-proposal on October 31, 2011, consistent with the general feedback provided in this meeting.

Also on October 31, 2011, FDA will provide an estimate of resources needed to achieve the program discussed with supporting data. FDA noted that the resource estimate they are generating will be specifically focussed on achieving the performance identified in proposed MDUFA III commitments. FDA also stated their belief that the program discussed reflects substantial improvements to address concerns Industry and FDA have identified; if agreement on funding can be reached, MDUFA III will put the medical device review program on a path toward solid improvement and success. FDA noted that one challenge the group will face is that preliminary estimates put the cost of this package above that which FDA proposed in April and May. Industry had indicated that FDA’s April proposal package was not acceptable.

Next Meeting

The next meeting will take place October 31, 2011.

Meeting End Time: 12:15 pm

1 For purposes of these minutes only, the term Industry refers to AdvaMed, MITA, and MDMA and does not include ACLA unless specifically noted.