FDA – Industry MDUFA III Reauthorization Meeting

June 1, 2011, 10:30 – 5:00 pm

FDA White Oak Building 1, Silver Spring, MD

Room 4101-4105


To discuss Industry’s proposals for the next reauthorization, as well as present data on workload issues and discuss additional FDA proposals.



Malcolm BertoniOffice of the Commissioner (OC)

Ashley Boam

Center for Devices and Radiological Health (CDRH)
Nathan BrownOffice of Chief Counsel (OCC)
Kate CookCenter for Biologics Evaluation and Research (CBER)
Natalia ComellaCDRH
Christy ForemanCDRH
William HubbardFDA Consultant
Elizabeth HillebrennerCDRH
Toby LoweCDRH
Thinh NguyenOC
Tracy PhillipsCDRH
Don St. PierreCDRH
Ruth WatsonOffice of Legislation (OL)
Barbara ZimmermanCDRH


Susan Alpert  Medtronic (representing AdvaMed)
Hans BeinkeSiemens (representing MITA)
Brian ConnellMedical Imaging Technology Alliance (MITA)
John FordAbbott Laboratories (representing AdvaMed)
Elisabeth GeorgePhillips (representing MITA)
Donald HortonLaboratory Corporation of America Holdings (representing ACLA)
Mark LeaheyMedical Device Manufacturers Association (MDMA)
Joseph LevittHogan Lovells US LLP (representing AdvaMed)
John MantheiLatham and Watkins (representing MDMA)
David MongilloAmerican Clinical Laboratories Association (ACLA)
Jim RugerQuest Diagnostics (representing ACLA)
Patricia ShraderMedtronic (representing AdvaMed)
Janet TrunzoAdvanced Medical Technology Association (AdvaMed)

Meeting Start Time:  10:30 am

Industry Presentations

ACLA discussed a proposal for how to address the inclusion of laboratory developed tests (LDTs) under the MDUFA reauthorization process.  ACLA noted all its members perform LDTs.  Some members have submitted or may submit pre-market submissions to FDA for clearance or approval for certain LDTs.  Before putting forward its proposal, ACLA reminded the group of characteristics that distinguish LDTs from other products currently regulated by FDA and that distinguish laboratories from other industry members represented in the negotiations, and noted some of the regulatory policy uncertainties specific to LDTs affecting ACLA’s participation.  ACLA proposed lower fees for laboratories submitting LDTs for review by FDA if FDA ends its policy of enforcement discretion regarding LDTs, noting that clinical laboratories would be subject to MDUFA user fees as well as Clinical Laboratory Improvement Amendments (CLIA) fees.  ACLA also proposed having more streamlined FDA performance goals for LDTs if FDA ends its policy of enforcement discretion regarding LDTs.  ACLA also proposed going forward and finalizing MDUFA negotiations under the current policy, with the understanding that user fees will not apply to this sector until a final regulatory framework for LDTs has been established.  Once the regulatory framework is established, ACLA wishes to see FDA reopen negotiations with the clinical laboratory sector.

The other Industry associations (AdvaMed, MDMA, and MITA) offered a presentation that reflects their shared position.  Industry stated its commitment to a successful program and provided a perspective of how the user fee program has evolved.  Industry discussed that FDA has not consistently met the MDUFA II quantitative goals for Original PMAs/panel track supplements, Expedited PMAs, PMA Modules and 180-day supplements. Industry also presented data showing that, although the 510(k) goals have been met, total elapsed time to decision for 510(k)s has increased since 2006.

Industry also claimed that FDA had not yet achieved some of the qualitative goals. Under MDUFA II, FDA committed to continuing to incorporate interactive review to facilitate timely completion of the review process. Industry cited FDA’s data, which found Interactive Review was utilized in 36% of submissions by ODE.  FDA noted that this figure is an underestimate.  In the commitment letter, FDA agreed to apply user fee revenues as resources permit to support reviewer training; Industry characterized FDA’s performance by asserting a lack of  focused and consistent training on core competencies and training to enhance scientific expertise, a lack of analysis of training effectiveness, and not holding vendor days in 2010 and holding limited reviewer site visits.   

Regarding the agency’s commitment during MDUFA II to review a list of low-risk IVDs to determine whether any of them could be exempted, while FDA has completed that review, Industry noted that FDA had not yet issued any exemptions. 

FDA committed to developing guidance documents to the extent possible without adversely impacting the timeliness of review of MDUFA-related submissions.  Industry claimed that there has been a lack of meaningful response to input from industry during the guidance process.   In the commitment letter, FDA also agreed to develop a guidance document regarding diagnostic imaging devices used with contrast agents, which FDA issued in 2009; Industry asserted that it has not worked as expected needs to be re-done.

A MDUFA II qualitative goal provided for FDA to make every effort to schedule meetings in a timely manner.  Industry offered its view that there is still difficulty in scheduling meetings. 

Discussion then moved to the current environment and industry’s concerns about uncertainty due to possible changes in 510(k), PMA, New Science Report and Innovation Initiative. Industry also raised the divergence of perspectives on current MDUFA II performance.  Based on these factors, Industry concluded that it would be impractical to develop meaningful goals and resource needs for a predictable 5 year program.

Industry stated that it supports the goals and objectives of the user fee program; however, they noted the system was currently in flux as we await policy decisions regarding LDTs and the IOM report on the 510(k) program.  Industry expressed concerns about developing meaningful goals and agreeing to associated resources for a five year program.   Industry noted its intent was not to abort the program, but rather, to wait for FDA to resolve these policy issues and to allow FDA additional time to achieve MDUFA II commitments.

Industry proposed to extend MDUFA II for only two years at the FY2012 authorized collection levels (allowing for a 4% inflationary increase each year).  FDA asked if Industry considered the funding shortfalls this would create for the program, given that this would represent a decrease in MDUFA user fee spending.  Industry acknowledged that there would be a decrease in MDUFA user fee spending.  Industry proposed that FDA would be given an additional two years to fulfill all of the quantitative and qualitative goals stated in the MDUFA II commitment letter; proposed to include a two-year extension of third party review; and, proposed an independent analysis of the management of the review process to be performed by an independent consulting firm.  Industry further expressed its expectation that average total time to decision would decrease toward 2003-2006 levels by the end of the two year extension.  When asked if this proposal would meet ACLA’s objectives also, ACLA responded it would require further consideration before providing an official response. 

Industry provided a list of future enhancements it would like see incorporated into future reauthorization of MDUFA.  The enhancements cover the following areas: the guidance development process, pre-submission meetings, refuse to accept/file practices, mandatory interactions, mandatory meetings, CLIA waiver application goals, and total time to decision goals. 

FDA indicated disagreement with certain aspects of Industry’s characterization of MDUFA II commitments as well as Agency activities during recent years, such as the rate of IR use and the characterization of site visits.  FDA asked clarifying questions regarding Industry’s proposal, but stated it was not in a position to provide an official response at this meeting.  FDA noted there would always be uncertainties in the program which all parties must face.  Currently FDA faces uncertainties regarding potential reductions in Budget Authority (BA), incoming workload, and regulatory reform agendas.  FDA noted that the funding level of Industry’s proposal would make it difficult to achieve any improvements and potentially lead to increased turnover of experienced reviewers due to burn out from continued lack of sufficient resources.  FDA agreed to discuss Industry’s proposal with FDA’s ratifiers.

FDA Presentation

In response to Industry’s request, FDA provided a quantitative analysis of reviewer activities based on ODE and OIVD time reporting data. Additionally, FDA explained the differences among the process for the review of device applications (which includes more than just the review of submissions), the devices and radiological health program, and total Center for Devices and Radiological Health activities.  The process includes CDRH time, CBER time, Office of the Commissioner (OC) time, and certain field work conducted by Office of Regulatory Affairs (ORA).  While all of these components of FDA contribute to the process of medical device review, the majority of work is contributed by CDRH. 

FDA explained how the full-time equivalent (FTE) staffing levels (derived values based on time reporting data) applied to the medical device review process have increased over the course of MDUFA II.  FDA and Congress recognized the importance of the Total Product Life Cycle (TPLC) and the matrix was created with targeted BA funding.  According to a comparative analysis of time reporting from 2005 to 2010, 30 new FTE contribute to this effort.  Because TPLC involves feeding post-market signals back into the pre-market process, it is considered part of the process of medical device review per statutory definition, but does not necessarily involve direct review of submissions with MDUFA goals.  Similarly, targeted BA funding was directed towards regulatory science through hiring of experts in the fields of nanotechnology, bioresorbable polymers, computational modeling, computer aided diagnosis, medical imaging displays.  FDA’s comparative time reporting analysis shows an additional 20 FTE focused on regulatory science in 2010 versus 2005.  These experts conduct research to support policy and guidance development, and review submissions, both of which are considered part of the process of medical device review.  The third major area of resource increases from 2005 to 2010 according to time reporting data is in pre-IDE (which includes all pre-submission) interactions.  An additional 65 FTE now contribute to pre-IDEs to address a workload which has doubled in this time.  FDA also presented data on total submission review workload, which includes all pre-market submissions for which FDA has time reporting data, including both fee-based and non-fee-based submissions.  This more complete measure of workload is calculated as the total number of submissions of each type multiplied by the average effort per submission type.  The data demonstrate that the total workload has increased by 27% since 2007.  Industry noted that the average number of fee-based submissions has been relatively flat.

FDA discussed a new proposal intended to make the third party inspection program more effective and promote its use.  Specifically, FDA proposed applying user fees toward expanding the number of accredited person auditors as well as the types of inspections to include Class I and II manufacturers not previously inspected.  FDA believes this proposal reflects a step towards a single audit program. 

FDA also briefed Industry on a revised proposal on clinical registries.  FDA proposed applying user fees toward the enhancement of epidemiologic methodologies and the assessment of the quality and utility of medical device clinical registries to support post-approval studies, and possible application to the pre-market arena, including identification of comparison groups. This work would be done through the MedEpiNet, a new public-private partnership in which FDA participates, which would provide Industry with analyses of available registries in a given device area and indication of their utility in addressing FDA requirements. 

FDA reiterated that they developed their overall proposal package, presented at the April 13th and May 4th negotiation meetings, with a goal of improving consistency, transparency, and predictability.  The additional resources included in the proposed package along with the program improvements are intended to reduce the number of review cycles, reduce overall time to final decision, and increase quality and timeliness of interactions and meetings.  In light of Industry’s presentation of a two-year extension, FDA determined that it would not be constructive to present its draft commitment letter language for a five-year reauthorization at this meeting. 

FDA agreed to discuss Industry’s proposal with FDA’s ratifiers and to provide formal feedback at a later date.  Additionally, FDA agreed to develop an agenda with Industry prior to meeting on June 17, 2011.

Next Meeting

The next meeting will take place June 17, 2011.

Meeting End Time:  5:00 pm