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Medical Devices

Minutes From Negotiation Meeting on MDUFA III Reauthorization: June 27, 2011

FDA – Industry MDUFA III Reauthorization Meeting
June 27, 2011, 10:15 – 2:30 pm
FDA Switzer Building, Washington, DC
Room 1007


To discuss MDUFA III reauthorization.


Malcolm BertoniOffice of the Commissioner (OC)
Ashley BoamCenter for Devices and Radiological Health (CDRH)
Nathan BrownOffice of Chief Counsel (OCC)
Kate CookCenter for Biologics Evaluation and Research (CBER)
Christy ForemanCDRH
Alberto GutierrezCDRH
William HubbardFDA Consultant
Elizabeth HillebrennerCDRH
Toby LoweCDRH
Tracy PhillipsCDRH
Ruth WatsonOffice of Legislation (OL)
Nicole WolanskiCDRH
Barbara ZimmermanCDRH
Susan AlpertMedtronic (representing AdvaMed)
Hans BeinkeSiemens (representing MITA)
David FisherMedical Imaging Technology Alliance (MITA)
John FordAbbott Laboratories (representing AdvaMed)
Tamima Itani (by phone)Boston Scientific (representing MDMA)
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)
James RugerQuest Diagnostics (representing ACLA)
Janet TrunzoAdvanced Medical Technology Association (AdvaMed)

Meeting Start Time: 10:15 am

Industry began with a presentation representing AdvaMed, MITA, and MDMA which provided a response to FDA’s proposal, offered a proposal for a process for mitigating uncertainties identified by Industry, and proposed four review process enhancements.

Industry stated that they do not agree with FDA’s initial proposal of $770M. They do not agree with FDA’s proposed baseline, which could result in an increase of 17% from FY 2012 collections to FY2013 collections in order to maintain projected FY 2012 user fee spending levels with 4% inflation. Moreover, Industry stated that there should be a separate in-depth discussion to better understand the divergence between authorized collections and spending under FDA’s MDUFA II spending plan. Industry stated that they do not support MDUFA III user fees comprising 40% of the device review budget (i.e., the process for the review of device applications). Industry stated they have always been concerned with user fees becoming too large a percentage of the overall budget. Comparison was made to PDUFA, under which user fees comprise over 60% of the drug review budget. FDA noted that comparing PDUFA and MDUFA user fees based on their respective percentages of review budgets obscures the large difference in the scale of PDUFA fees compared to MDUFA fees. Industry responded that the drug and device industries are in different markets and new drugs receive greater revenues. Industry stated their concern about the perception of FDA relying too much on user fees for the device review budget. Industry also noted that the inclusion of the appropriation trigger, which was intended to ensure adequate budget authority appropriations in MDUFMA and MDUFA II, is an indication of the importance of this issue to Industry.

Regarding qualitative goals, Industry stated that they will need more specificity and clarity compared to the MDUFA II commitment letter. Industry does not agree to funding FDA’s registry proposal nor the additional aspects of the 3 rd party inspection proposal that FDA presented on May 4, 2011. Industry stated that their June 1 st proposal was a complete and constructive counter proposal offered in good faith. Additionally, Industry stated that FDA’s initial proposal for mitigating uncertainties was not adequate.

Industry presented its plan for mitigating uncertainties, beginning by reiterating that they are committed to working in good faith to reach an agreement and that they do not believe this process is out of line with the timelines of previous rounds of negotiations. Industry believes that transparency is needed for proposed FDA reform in order to assess workload and resource impact. Industry is unwilling to agree on a final package until all relevant information is known and sufficiently addressed for workload and resource impact. Industry asserted that FDA’s initial proposal for mitigating uncertainties would involve getting too far down the road without enough information.

Industry’s plan for mitigating uncertainties addressed the following areas of concern: IOM report, 510(k)/Science implementation plan, regulation of Laboratory Developed Tests (LDTs), and “other initiatives”. Industry indicated the need to understand the workload and resource impacts of each of these areas.

To manage Industry’s uncertainty regarding the IOM report, Industry proposed that, within 15 days of the report being issued, the negotiation teams meet to discuss the report recommendations and the potential impact of the recommendations on CDRH’s workload and resources. FDA pointed out that this discussion of workload assessment would take place prior to FDA making a determination of action on the recommendations and, therefore, would be a discussion on recommendations that might never be implemented. Industry further proposed that FDA would subsequently issue a plan related to each of those recommendations with a workload and resource impact analysis.

Industry requested additional detail for the following 510(k) implementation actions: 510(k) paradigm, 510(k) modifications, de novo guidance, Third Party review program SOP, and multiple predicate analysis. Industry acknowledged that FDA provided an overview of which of these initiatives would have a resource implication and which would not, but Industry would like a more detailed impact analysis on workload and resources. Industry would also like to provide comments on the impact analysis. Industry clarified that they are looking for numbers regarding the expected increases in submissions, how specific recommendations will affect the size and scope of submissions, when such impacts would occur during the MDUFA III period, etc. FDA provided clarification on the multiple predicate analysis, confirming that FDA is not limiting predicates, but will be clarifying how predicates may be used in accordance with the statute. FDA indicated that this clarification is not expected to affect 510(k) workload.

Industry stated that they need to know FDA’s plans for regulating LDTs prior to reaching a final agreement, and that they want FDA to prepare an impact analysis on workload and resources related to the regulation of LDTs. Industry is concerned that regulation of LDTs will affect FDA’s ability to meet its performance goals because of increased workload. FDA reiterated its plan to address LDTs through a risk-based, phased-in approach, and therefore the Agency does not expect a large impact on workload. FDA’s plan for LDTs will be published as guidance and will have a comment period. FDA clarified that there are expected to be three guidance documents coming out together that will detail the proposed road forward in oversight of laboratory developed tests. One will address the overall framework, one will address the means by which FDA will gather information on what LDTs are being offered, and one will help laboratories understand the differences and similarities between CLIA regulations and the Quality System Regulations (QSRs). ACLA stated that it has communicated its position regarding the distinguishing factors between LDTs and test kits and would be amenable to including a statement in the commitment letter to the effect that LDTs would not be included in MDUFA III if there is truly a minimal impact on workload.

Finally, Industry indicated that there are additional initiatives for which it wants FDA to prepare impact analyses, such as a PMA initiative and the Innovation Initiative, and any additional plans for programmatic changes. Industry stated that FDA appeared to be on the verge of issuing many things. Industry wants to know what is involved, especially since FDA is requesting additional resources. FDA clarified that the only currently active initiative related to PMAs is the innovation pathway, which is targeted for truly innovative products as a way to potentially address expedited issues. However, it is currently a pilot and FDA is not resourced to expand it.

FDA noted that it is hard to determine all of the factors that will affect workload over a five-year period. There will always be some unknowns and FDA is not sure they will be able to get to a place where Industry is comfortable if there is no clear stopping point regarding the level of information FDA is asked to provide. Industry stated that they are willing to accept some unknowns as long as there is a workload analysis showing the known impact and outlining the unknowns. FDA expressed concern about the timeline because some of these issues are not scheduled to be resolved until mid- or late Fall, such as the issuance of guidance documents on the 510(k) paradigm, the de novo process, multiple predicate analysis, and the third party review SOP. Additionally, FDA is concerned that there will always be another uncertainty that Industry will want mitigated before reaching an agreement.

In response to a clarifying question from FDA, Industry confirmed that if the uncertainties are mitigated sufficiently, that will allow the possibility for Industry to negotiate a five-year program. FDA reiterated the need to meet the negotiation timeline, given that Congress has specifically asked the FDA Commissioner to meet the statutory deadline of transmitting final recommendations by January 15, 2012. FDA also stated that it needs to understand what level of assurance Industry is requesting and what it will take to satisfy them in terms of mitigating uncertainty in each of these areas. Industry explained that they will not address any proposals for improving the management infrastructure, hiring additional people, etc., until they have a better understanding of what the workload will be as a result of the various initiatives currently undertaken by FDA that Industry identified as areas of concern (described above).

Industry indicated that they are willing to move forward with working groups in parallel while a process for mitigating uncertainties is being carried out, but that the uncertainties must be resolved before they can commit to a final agreement. FDA asked when Industry can put the rest of their proposals on the table. Industry stated that they have been working on them and could put them on the table quickly once an agreement is reached on a process for mitigating uncertainties, but they will not finalize an agreement until they know the impact of the proposed changes identified by Industry.

Industry presented four proposals for review program enhancements: pre-submission meetings, refuse to accept procedures for 510(k)s, refuse to file procedures for PMAs, and an independent analysis of review process management.

Industry is in agreement that pre-submission meetings are valuable and that they can help improve the overall time to market. Industry therefore proposed that such meetings be held within 45 days of a request, that FDA come prepared to inform the applicant of data requirements, that the sponsor provide draft minutes within 10 days of the meeting, that FDA provide final comments on the minutes within 20 days of receiving the draft, and that any follow-up meetings in the same lineage be held within 30 days. FDA explained that in fiscal year (FY) 2010, the Agency received approximately 1,100 pre-IDEs (which FDA plans to rename “pre-submissions” upon publication of the guidance to more accurately reflect their use relating to all types of submissions, not exclusive to IDEs). Many of those submissions were resolved with either a written response or teleconference rather than a meeting. FDA asked if Industry’s proposal is that every pre-submission be discussed in a meeting, noting that increasing the overall number of meetings would have a significant impact on resources. Industry asked for a breakdown of what percentages of pre-IDEs are resolved with a meeting or without a meeting, but such data are not available from FDA’s tracking system. Industry replied that the goal of the proposal is not to increase the overall number of meetings, but to add structure to make meetings more meaningful to both parties. FDA also asked how the proposal to provide “data requirements” would apply to meetings intended to introduce new technologies to FDA, discuss regulatory classification, discuss submission strategy and timing, or other topics that are not necessarily associated with data requirements. Industry indicated the proposal is intended to focus on true pre-submissions (i.e., when Industry is actively preparing an IDE or marketing submission to be sent to the Agency in the near term). FDA and Industry discussed the pre-submission guidance currently in development and expected to publish in draft this November. In response to Industry’s questions, FDA confirmed that the goal of the guidance is to harmonize the pre-submission and meetings process across ODE and OIVD. Industry emphasized that the objective of this proposal is to set an expectation for earlier, meaningful interactions.

Industry presented counter-proposals to FDA’s April 13, 2011 proposals on refuse to accept procedures for 510(k)s and refuse to file procedures for PMAs. Industry’s goal with these proposals is consistent with FDA’s: to avoid expenditure of FDA resources on incomplete submissions. For 510(k)s, Industry proposed that an “acceptance review” be conducted against the current objective criteria for missing basic information similar to the approach proposed by FDA on April 13, 2011; Industry proposed that this review would occur within 15 days of receipt. For PMAs, Industry proposed a two step review similar to FDA’s proposal, with an initial “level 1” filing review conducted by Program Operations Staff within 15 days of receipt followed by a “level 2” review conducted by the lead reviewer within 45 days of receipt. Industry proposed a 25% user fee penalty for submissions which fail to meet “level 2” review, akin to the MDUFA II approach for submissions that are not filed. For both 510(k) and PMA procedures, Industry proposed to establish working groups to develop the objective criteria and that they be incorporated into the commitment letter. Industry also requested annual analysis and reporting of rejection rates. In response to a question from FDA, Industry explained that under their proposal, a submission that is not accepted/filed would not result in the clock starting. In response to another FDA question, Industry indicated that the “level 2” PMA review would remain consistent with filing criteria from the regulations.

Similar to FDA’s April 13, 2011 proposal and Industry’s June 1, 2011 proposal, Industry presented a counter-proposal for an independent analysis of review process management conducted by a management consulting group. Industry proposed that the analysis should include: evaluation of the process for allocating resources to achieve maximum efficiency and consistency, analysis of root causes of preventable delays, identification of best practices for good reviews, and identification of steps to correct identified inefficiencies. FDA indicated that the federal contracting process would not allow for Industry consultation in the selection of the contractor. Industry replied that they are mostly concerned with the type of consulting firm, not with selection of one over another. In response to FDA’s question, Industry clarified that this analysis should be performed early in MDUFA III, likely within the first 2 years, to develop a baseline for future program evaluation.

Industry noted that the four proposals presented do not reflect an exhaustive list; additional proposals are being developed in areas indicated in the May 4, 2011 and June 1, 2011 Industry presentations. Industry would agree to present the complete list of proposals to FDA promptly once agreement is reached on a process for mitigating uncertainties.

Next Meeting

The next meeting will take place July 15, 2011.  

Meeting End Time: 2:30 pm

Page Last Updated: 07/16/2014
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