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Medical Devices

Minutes From Negotiation Meeting on MDUFA III Reauthorization: August 2, 2011


FDA – Industry MDUFA III Reauthorization Meeting

August 2, 2011, 10:20 – 3:15pm

FDA Switzer Building, Washington, DC

Suite 1100



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)

Natalia Comella


Christy Foreman


William Hubbard

FDA Consultant

Elizabeth Hillebrenner


Toby Lowe


Thinh Nguyen


Tracy Phillips


Don St. Pierre


Ruth Watson

Office of Legislation (OL)

Nicole Wolanski


Barbara Zimmerman





Susan Alpert

Representing AdvaMed

David Fisher

Medical Imaging Technology Alliance (MITA)

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 (MDMA)

John Manthei

Latham and Watkins (representing MDMA)

David Mongillo

American Clinical Labs Association (ACLA)

Jim Ruger

Quest Diagnostics (representing ACLA)

Patricia Shrader

Medtronic (representing AdvaMed)

Janet Trunzo

Advanced Medical Technology Association (AdvaMed)


Meeting Start Time:  10:20 am



FDA Feedback on Industry’s July 26th Proposal


FDA offered preliminary remarks to provide context for their feedback on Industry’s proposal presentation from July 26th.  FDA noted that balance and flexibility are needed to meet the key program objective of “timely access to safe and effective devices while fostering innovation.”  FDA suggested that, if appropriately balanced, solutions with the following features should lead to a successful program that is more transparent, consistent, and predictable: clarity of expectations, shared risk and accountability, appropriate incentives and metrics, flexibility to achieve outcomes, and simplicity and efficiency of mechanisms.  FDA also emphasized the need to avoid unintended consequences. 


FDA described the general format of their comments, which included for each proposal: identification of the underlying objective, and potential concerns or challenges; in addition, for some proposals FDA identified potential unintended consequences, and questions for Industry.  FDA emphasized that their intention was to provide constructive feedback; recognition of potential problems and unintended consequences does not preclude further discussion of the proposals, but rather indicates areas that would need to be addressed.  FDA also emphasized that many of Industry’s proposals have potential resource implications.  Industry stated that further discussion about FDA’s financial information and completion of development of performance goals are required before industry would be willing to discuss the costs of the package. 


Quantitative Goals

FDA noted that Industry put forward a set of proposals with the underlying goal of trying to get timely access to safe and effective medical devices by reducing total time to decision.  FDA expressed concerns that no obvious mechanism was proposed to account for Industry’s share of total time to decision.  As presented, it appears that the resources required to implement these goals would be substantial.  For example, in FY 2010, most 510(k) submissions would not have met Industry’s proposed goal.  FDA noted that the simpler the goal structure, the easier it is for reviewers to manage and balance workload.  Annual changes to goals as well as a complex goal structure would make it difficult for reviewers to manage their portfolio and track when an application is due.  FDA indicated that a simpler structure would be easier to implement.  


FDA also highlighted some potential unintended consequences with Industry’s proposal.  For example, under this goals structure, FDA’s ability to assist submitters might be limited to the pre-submission process.  As Industry’s proposal does not include a mitigation strategy for addressing a sponsor’s contribution to a total time goal, time constraints might not permit FDA to assist a sponsor in getting its application into an approvable or clearable form mid-review.  When asked if FDA would stop using interactive review, FDA noted it would still use interactive review, but might have to limit its use to issues that could be easily clarified or readily resolved.  For example, an issue that emerged during a review that could not have been anticipated before submission and requires follow-up (e.g., product not passing biocompatibility testing), could not be addressed during the total day goal proposed.  FDA expressed concerns that the goals would restrict flexibility and could result in decreased rates of approvals and clearances, at least in the short term.  FDA also speculated that not substantial equivalent (NSE) rates due to lack of adequate performance data might go up in the beginning.   Industry acknowledged there will be a transition period, but speculated that a stable base line could be achieved.  FDA also pointed to an example of an unintended consequence from MDUFA II.  An option to send a major deficiency letter was added to PMA supplements, which resulted in longer total times as FDA made additional efforts to get submissions to approvable form.  Under Industry’s proposed goals for total time, such efforts could not be accommodated. 


Pre-submission Meetings

FDA agreed with the underlying objective of clarifying data requirements prior to submissions.  This is an important step toward ensuring a positive outcome on a submission. 


FDA raised concerns regarding the resources needed for Industry’s pre-submission meeting proposal.  Depending on the number of meetings requested, costs would include additional reviewers, additional managers, IT, conference space, etc.  An increase in meetings would require increased management infrastructure.  Industry inquired about stated IT needs; FDA noted it tracks pre-submissions and the outcomes of those interactions, but it does not currently have the capacity to track meetings.  FDA further noted that the proposal would require a change in FDA practice.  Currently, in many cases, FDA schedules a meeting at Industry’s request without Industry having to submit complete pre-meeting materials until two or three weeks prior to the meeting.  To meet anticipated demand, FDA might need to change practices to a more formal structure, requiring a complete “pre-submission” at the time of the meeting request. 


FDA also noted that a more formal pre-submission meeting structure might result in more conservative scientific feedback due to the more formal nature proposed.  This comment was based on historical experiences with Product Development Protocols (PDPs) and Determination and Agreement meetings, neither of which seem to have worked well for Industry due to their binding nature and FDA’s tendency to take a more conservative approach to such meetings.  Industry clarified that their proposal was trying to address concerns about FDA not being held accountable for following through on what was said during early interactions.  FDA noted two factors that might result in a change in FDA’s initial feedback: a significant time lag between the initial feedback and the submission, and/or changes or advancements in science over time from which new concerns emerge that render the feedback outdated. 


FDA asked Industry clarifying questions around how feedback can be communicated and how Industry defines the types of submissions/interactions in the pre-submission category.  Industry replied that feedback could come in various non-meeting formats, such as e-mail or phone calls, and that additional discussion is needed to define the pre-submission category.

Mandatory Interactions 

FDA agreed with the underlying objective to ensure transparency and efficiency of review through substantive interactions.


FDA indicated that imposing mandatory meetings on numerous submissions could require substantial additional resources.  They would require additional reviewers and managers.  As proposed, this would require increased management in order to prepare for and attend the meetings.  FDA may also be limited by the number of conference rooms available, and there would be logistical challenges in scheduling given that it would not always be clear which submissions would need meetings.  As proposed, if the Tier 1 510(k) goal is missed, there would be a mandatory meeting.  Industry clarified that the meetings do not have to happen in person.  


FDA raised a potential concern that mandatory meetings could divert resources from completing review of submissions that could potentially meet the Tier 2 goal.  Industry clarified that its intent was to ensure communication between the Agency and the sponsor so that Industry is clear on the status of the submission.  FDA noted that by better understanding Industry’s intent, the group can have a dialogue to figure out the best way to address the potential problem.


FDA asked why Industry proposed two mandatory meetings between the Tier 1 and Tier 2 goals.  Industry explained that the idea is to ensure interaction and clarified that the day 100 meeting was proposed for submissions that had missed the Tier 1 goal and for which there had been no substantive interaction up to that point.  FDA noted that the proposed goal for substantive interaction by day 30 is challenging and resource-intensive, and is significantly more aggressive than what FDA proposed. 



FDA concurred with Industry that implementation of objective criteria for Refuse to Accept (RTA) and Refuse to File (RTF) screening would be beneficial in minimizing resources spent on applications containing insufficient information. 


FDA noted that any changes or amplifications to the RTA and RTF criteria would likely need to be implemented through guidance or rulemaking.  FDA and Industry could hold conceptual discussions of objective criteria.  The proposal for a special RTF appeals process presented potential legal challenges; however, FDA noted that a forthcoming draft guidance on appeals might address Industry’s concerns that appeals take too long. 


Both sides noted the need for further discussion on this issue.  Industry suggested the Agency could exercise creativity in its process for implementing the criteria, such as using negotiated rulemaking.  Industry raised concerns about FDA changing the current objective criteria, as the rate of RTAs could increase.  FDA noted that both parties are in agreement on not wasting time on applications with insufficient data.  Furthermore, FDA pointed out that the Agency has not been enforcing the existing RTA/RTF policy.    


CLIA Waiver

FDA agreed with the underlying objective to have a more timely and transparent process for Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application submissions.  FDA reminded the group that there are devices that are waived by regulation; the Agency’s feedback only applies to those submissions that are waived by application.


FDA also pointed out that a waiver study has different statutory criteria and, while it is associated with a 510(k) or a PMA, it is not a 510(k) or a PMA.  To implement Industry’s proposal for performance criteria, the Agency would need to establish a new submission type for tracking purposes.  This would also require development of an internal tracking system that links to the public CLIA database. 


The Agency asked if Industry hoped to see the adoption of concurrent marketing application and CLIA waiver reviews.  Industry clarified that they proposed both options for concurrent and sequential reviews.  FDA noted that the pilot program conducted (during MDUFA II) demonstrated that a concurrent process only extended review times, as a change in one submission resulted in the need to restart review of the other. 


In response to Industry’s proposal to revise the CLIA guidance, FDA noted that this would require involvement of the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC), which are two other operating divisions of the Department of Health and Human Services.  FDA explained that CLIA is CMS’s program.  Changes to administrative guidance may be appropriate, but substantive policy changes would be outside the scope of MDUFA negotiations. 


Additionally, the Agency noted that the CLIA statute provides for collection of user fees by CMS as necessary to administer the program.  CMS provides some of these funds to FDA to perform waiver reviews.  As a result, a MDUFA proposal that involved the use of user fees for CLIA reviews would need to be analyzed under the CLIA statute.  Industry pointed out that one of the MDUFA II commitments was to track CLIA waiver application review times for the purpose of evaluating whether CLIA waiver user fees and performance goals should be considered for MDUFA III.


Third Party Review Program

FDA agrees with Industry’s objective to improve the third party review program.  FDA noted that there is no staff to oversee the program, and suggested that improvements should include additional Program Operations Staff dedicated to providing oversight.  FDA pointed out additional resource implications for training of third parties, bioresearch monitoring (BIMO) audits, and CDRH’s Division of Small Manufacturers, International and Consumer Assistance (DSMICA) certification program.  As it currently stands, this is an unfunded activity for the Agency.  To meet Industry’s proposal for publishing third party review memos, additional resources would be required for redaction and reviews to ensure compliance with Section 508 of the Americans with Disabilities Act (ADA) regarding accessibility of documents published online. 


De Novo

FDA agrees with Industry’s underlying objective of improving timely access to safe and effective innovative devices through improving the de novo system. 


FDA noted that Industry’s proposal to eliminate the need for NSE prior to the de novo step would require a statutory change.  FDA also indicated that completing the review for a novel product and the generation of special controls all within the 510(k) performance goals, as proposed by Industry, would require a significant increase in review resources.  FDA is publishing draft guidance with the intent to streamline the de novo process. 


Reviewer Point System

FDA agreed that improving consistency and responsiveness of reviewers through appropriate performance incentives is a shared underlying objective. 


FDA noted it is trying to address attrition within CDRH, as its high attrition rate (especially when compared to CBER, CDER, and NIH) has a significant impact on productivity.  FDA’s proposal addressed this goal via retention bonuses based on specific eligibility criteria for certain disciplines.  Under FDA’s current performance system, reviewers can receive as an award a percentage of their salary in cash or equivalent “time off.”  However, the pool of resources available for these performance awards is limited to less than 2% of Center payroll, so the amount awarded to a reviewer is small.  Industry inquired how those who did not use IR scored versus those who do.  FDA reminded Industry that good data on IR usage do not exist given current limitations to tracking; however, FDA considers IR a tool for meeting goals which are tracked and considered in performance ratings.


Industry noted that the U.S. Patent and Trademark Office (PTO) has recently implemented a point system which has been credited with improving reviewer responsiveness and reducing PTO’s backlog.  The Agency noted some potential concerns with implementing that specific system.  The Agency already has a performance management and assessment program (PMAP) that is mandated by the Department of Health and Human Services, and is concerned that Industry’s proposal would not adequately address the Agency’s concerns with  high attrition rates.  As presented, additional resources would be needed to implement such a proposal at any level.  Also, such a program would need to include a way to ensure that “points for performance” is not interpreted as rewards for approvals or faster reviews without regard to appropriate review standards.  Industry also stated that PTO points were not awarded for issuing more patents. 


Independent Third Party Audit

FDA agreed that outside expert management review and recommendations would be helpful. 


FDA stated that the selection of an audit firm is an inherently governmental function, but the type of firm and key elements to be included in the scope of work could be discussed within MDUFA negotiations.  FDA suggested that a more successful approach may be to focus most of the effort on an initial, intensive external evaluation, with a more limited scope for annual external audits, but is open to discussing this further.  FDA also clarified that that the evaluation should assess both FDA and Industry contributions to the review process.  On the Industry side, this would include submission quality and Industry interactions, but would not require any site visits.  Industry responded that the intent of the audit is to look as FDA performance related to process issues and that details could be further discussed.


CDRH Dashboard

FDA expressed a willingness to provide more detailed information on progress made toward accomplishment of MDUFA commitments.  FDA noted that it currently presents data quarterly on MDUFA performance goals; providing additional information can be considered.  FDA does not currently have a system for tracking applications through the submission’s entire life cycle (pre-submission to application).  Implementation of such a system would require creating a product identification system, which may be very costly and difficult to develop.  Industry inquired whether FDA was able to track a submission once a 510(k), PMA or PMA supplement was submitted. FDA stated they were able to track this internally.  Industry suggested that an option would be to develop a dashboard for companies for each submission, similar to what the US Patent and Trademark office offers patent submitters to track their applications through the process.



FDA agrees with the goal of expanding and improving the effectiveness and transparency of premarket reviewer and management training.


FDA has taken several steps to address reviewer and management training: many program-specific courses are currently available on CDRH Learn; CDRH Staff College offers courses in a variety of topics; vendor days and site visits offer hands-on experience; the Leadership Readiness Program provides pre-managerial training; and FDA is preparing to launch a reviewer certification program this Fall which will require reviewers to take pre-identified courses to establish and maintain medical device regulatory knowledge.  Industry requested to be consulted on the development of training programs.  


FDA noted the extent of the premarket training program is subject to the funds available to support the program.


Management Practices (ISO 9000)

FDA appreciated Industry’s suggestion that they adopt standard management systems principles and practices.  However, FDA questioned whether ISO 9000 is the right model, and whether the benefits of formal registration outweigh the costs.  


3-Person Panel

FDA noted existing mechanisms to leverage outside expertise: Advisory Committees, Homework Assignments, Network of Experts, Dispute Resolution, and Appeals Mechanisms.  FDA suggested that these mechanisms may be sufficient, yet additional discussion on how to use them may be needed.  FDA also further explained the Network of Experts, which is a new initiative generated by the New Science Report.  Specifically, FDA is looking at establishing networks to provide advice on issues such as general, non-application-specific topics, such as nanotechnology.  These experts would be used to augment existing staff to provide access to areas of expertise that may not currently reside on staff. Industry expressed concern with how experts may be selected. 


Because Industry’s proposal involves outside assessment of confidential submissions, FDA pointed out that it would need to overcome FACA and Conflict of Interest implications.  Additionally, if used during the review process, FDA would not be able to meet the goals proposed. 


Discussion of Next Steps


FDA reiterated their concern with the negotiation schedule, indicating that an agreement must be reached in a matter of weeks in order to incorporate all of the public review steps required prior to the January 15, 2012 deadline for transmitting recommendations to Congress, as required by statute.  Industry indicated it was more important to “get it right” than to be finished by a certain date.  FDA also expressed concern that Industry’s proposals may be significantly more expensive than the estimates FDA provided on May 4, 2011 for their proposal package.  FDA also indicated that the Agency is only willing to move forward with working groups in the context of a five year reauthorization.  Industry indicated that it viewed the five year reauthorization as an open matter for negotiation.


Next Meeting


The next meeting will take place August 9, 2011.


Meeting End Time:  3:15 pm

Page Last Updated: 07/16/2014
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