Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Medical Devices

Minutes From Negotiation Meeting on MDUFA III Reauthorization: July 26, 2011


FDA – Industry MDUFA III Reauthorization Meeting

July 26, 2011, 10:30 – 4:00 pm

FDA White Oak Building 1, Silver Spring, MD

Room 4101-4105



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


Elizabeth Hillebrenner


Toby Lowe


Thinh Nguyen


Tracy Phillips


Ruth Watson

Office of Legislation (OL)

Nicole Wolanski


Barbara Zimmerman





Hans Beinke

Siemens (representing MITA)

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)

Joseph Levitt

Hogan Lovells US LLP (representing AdvaMed)

John Manthei

Latham and Watkins (representing MDMA)

David Mongillo          

American Clinical Laboratories Association (ACLA)

James Ruger

Quest Diagnostics (representing ACLA)

Patricia Shrader

Medtronic (representing AdvaMed)

Janet Trunzo

Advanced Medical Technology Association (AdvaMed)



Meeting Start Time:  10:40 am


Industry Proposal


Industry began with a joint AdvaMed, MDMA, and MITA presentation of a proposed performance package.  As previously agreed, the proposal did not include financial information.  Industry emphasized their desire to see a reversal in the trend of increasing total time to decision for 510(k)s.  Industry’s package included proposals in the following areas: submission acceptance criteria, review of applications, qualitative goals, and measurement/audit. 


Submission Acceptance Criteria


Pre-Submission Meetings

Industry proposed pre-submission meeting requirements for all submissions, including CLIA waiver applications, with a quantitative goal that 98% of pre-submission meetings would be held within 45 days of request.  Industry intends for these meetings to lead to an agreement between the Agency and the Sponsor on data requirements for the pending submission; changing these requirements would require both a scientific rationale and Division-level management approval.  Industry proposed that the Sponsor would submit minutes within 10 calendar days of the meeting and FDA would provide a response to the minutes within 20 calendar days of receipt; a lack of response would indicate FDA’s acceptance of the Sponsor’s minutes.  Industry also proposed that follow-up meetings be held within 30 days of request.  Industry stated that pre-submission meetings can be a major driver toward the goal of reducing overall time to decision.



Industry also proposed Refuse to Accept (RTA) procedures for 510(k) submissions and Refuse to File (RTF) procedures for PMA submissions.  Industry’s proposal included several elements in common with the approach that FDA discussed at the April 13, 2011 meeting, including the Agency’s intent to clearly define objective criteria for what constitutes a complete submission, to implement checklists for RTA for IDEs and 510(k)s, and to add an administrative RTA checklist to the current RTF criteria for PMAs. 


Review of Applications

Mandatory Interactions

Industry proposed mandatory interaction goals as well as quantitative submission review goals.  Industry acknowledged that the goals they proposed are aggressive.  All Industry-proposed quantitative review goals are measured in total calendar days (i.e., covering both FDA time and Industry time), rather than the existing approach of FDA review days.  In response to questions from FDA, Industry acknowledged that its proposal did not include a mechanism for accounting for the time Industry takes to respond to requests for additional information or deficiencies identified by the Agency, but indicated a willingness to discuss this FDA concern.  FDA noted that current practice is to use discretion to allow Industry longer times to respond to such requests than the regulations allow, such as allowing 90 days (with an extension to 180 days) to respond to a request for additional information on a 510(k) when the regulation allows 30 days, and allowing 180 days with an extension to 360 to respond to major deficiency letters for PMAs when the regulation only allows for 180 days.  Industry acknowledged that they did not address this and recognize it as a challenging issue.


Industry proposed that a specific percentage of submissions receive a substantive interaction within 30 calendar days for 510(k)s, 45 days for CLIA waivers, and 90 days for PMAs.  For cases in which no previous substantive interaction has taken place, the proposal includes specific time frames for mandatory meetings after Tier 1 or 2 goal dates are exceeded.


Quantitative Goals

Industry proposed that 510(k)s have a Tier 1 goal that a specific percentage of submissions would have a MDUFA decision in 90 days, increasing by 5% each year, and a Tier 2 goal that a higher percentage would have a MDUFA decision in 180 days, with a goal for  average review time for submissions not meeting the Tier 1 goal.  Industry also proposed that a specific percentage of reviewer summaries be posted to the Agency’s website within 30 days for 510(k)s with Substantially Equivalent (SE) decisions.  The Agency indicated that meeting these goals would be very resource intensive.


For PMAs, Industry proposed a 3-Tier goal structure for Original PMAs that are not submitted to an Advisory Panel for review; a 2-Tier goal structure for Original PMAs that are submitted to an Advisory Panel for review; and 2-Tier goals for 180-Day PMA supplements, PMA Modules, and Real-time review PMA supplements.  FDA noted the difficulty in managing to the proposed 3-Tier goal structure.    


FDA asked clarifying questions in regards to Industry’s proposed goals for 510(k) and PMA submissions.  Industry indicated that they used 2006 data in order to set performance goals for 510(k)s. FDA noted that in 2006, when the average total time to decision for 510(k)s was lower than it has been in recent years, the total time to decision for  PMAs was significantly longer than Industry’s proposed goals, such that FDA was not close to meeting the full set of proposed goals.  FDA noted that the same review staff work on both types of submissions, so performance for both is intertwined.


Industry proposed a mandatory meeting within 30 days if FDA cites clinical trial design issues in an IDE disapproval.  They also proposed applying 510(k)-like goals to de novo applications and changing the statute to eliminate the need for a Not Substantially Equivalent (NSE) decision prior to submission of a de novo application.  Industry also proposed that CLIA waivers have the same performance goals proposed for 510(k)s and proposed the development of a revised CLIA waiver guidance document with substantive input from Industry.  Industry did not make a proposal for CLIA waiver applications that are submitted on PMA devices. 


Industry proposed reauthorizing the third party review program, developing a training and certification program for third party reviewers, establishing a process to keep third party reviewers current on FDA review considerations, and having FDA publish a specific percentage of third party review decision summaries on the FDA website within 30 days.  They also proposed establishing an Agency-Industry task force on third party review to meet twice a year.


Qualitative Goals

Guidance Documents

Industry proposed that the Agency develop a method of indicating which guidance documents are current and which no longer reflect the thinking of the Agency.  They also proposed that the Agency publish a prioritized list of guidance documents to be developed each year, with a performance goal where a specific percentage of those listed as Tier 1 to be published in the current year, and those listed as Tier 2 to be developed as resources permit.  They also requested Industry input into the guidance development process.



Industry proposed improving reviewer training by publicizing the training curriculum and gaining Industry input into the curriculum content.  Industry requested representation on any team of external experts, and a minimum of two Vendor Days per year each for OIVD and ODE.  They also proposed mandating improved management training.


Update Review Point System

Industry proposed incentivizing reviewers through a reviewer point system, similar to a system utilized at the US Patent and Trademark Office (USPTO), intended to reward those reviewers who follow SOPs and are consistent in their review practices.  The Agency expressed concern that given some significant differences between the USPTO and FDA, the model Industry proposed may not have the intended effect, and may not address FDA’s concerns about retention of experienced reviewers. 


Leveraging External Experts

Industry proposed establishing an external, three-person expert committee to adjudicate disagreements between FDA and Industry on specific product submissions, for which Industry would select one member, the Agency would select one, and the third would be mutually agreed to. 


Establish CDRH ID

Industry also proposed implementing a dashboard system to track products through CDRH, allowing Industry to follow the status of their submissions. 



Industry proposed quarterly MDUFA updates with more detailed information than previously provided.  They also proposed an independent annual audit of Agency performance to make recommendations for corrective actions and to improve Agency efficiency. 


ACLA Statement


ACLA provided a statement of its revised position.  ACLA proposed that the clinical laboratory industry and laboratory developed tests (LDTs) should not be subject to user fees under MDUFA III.  Their position specifically applies to those tests that have been subject to an enforcement discretion policy.  ACLA’s position was partially informed by the current uncertainties regarding when and how LDTs will be regulated.  ACLA also noted the burden the user fees would pose to this industry and highlighted its previous position – that if subject to fees, the fee structure would need to take into account that this community already pays fees to the Centers of Medicare and Medicaid Services (CMS).  ACLA clarified that its position did not apply to in vitro diagnostic (IVD) test kit products for commercial distribution to be used by third parties in third party laboratories. 


FDA Initial Response


FDA asked clarifying questions and offered its initial observations regarding Industry’s and ACLA’s proposals.


FDA thanked Industry for offering its proposals.  FDA identified a few potential issues or concerns with some of the proposals as presented.  The Agency noted that there are particular boundaries (pertaining to policy) that are not appropriate for discussion in the MDUFA negotiations, the scope of which relates to performance and goals for the user fee program.  FDA explained that policy issues would need to be addressed in the appropriate venue outside of MDUFA negotiations.  FDA highlighted a few examples in Industry’s proposal package that raised this potential concern.


Also, FDA noted certain proposals that could pose potential legal issues, including issues relating to how certain commitments would be implemented and memorialized, and whether certain goals or topics were within the scope of MDUFA.  FDA and Industry agreed to discuss these issues in greater detail. 


FDA highlighted the significant gap between the current goals established in MDUFA II and Industry’s proposed goals for MDUFA III.  FDA raised concerns that the Agency would be expected to meet significantly more aggressive targets, measured against a different metric (total days), in the first year of MDUFA III.  FDA inquired what analysis had been done to select these performance targets, and noted that Industry’s proposal, including those aspects intended to assist in meeting the proposed goals, would require implementation time and could not necessarily be implemented at the very beginning of MDUFA III. 


FDA also raised concerns about the need under total time goals to hold sponsors accountable for their portion of the total time to decision and incentivize timely and complete responses to FDA requests.  Industry stated it understood the challenges posed by the proposed goals and expressed an interest in hearing FDA’s ideas.  FDA encouraged Industry also to consider ways to address this issue, given that success under this goal would require shared commitment.


FDA noted that both parties agreed to discuss the financial aspects of Industry’s proposal after the initial presentation of the Industry proposal package; however, FDA raised concerns about how the parties can best advance discussions and hold a productive dialogue regarding proposals, given the tight time frame, without a general sense of the parties’ respective resource estimates and expectations about the relative cost of the proposal packages.  FDA encouraged Industry to think about priorities and the parameters of the proposals, given that several proposals appeared to require significant time and resources to implement.  Industry encouraged FDA to note which proposals might be more resource intensive, as that would affect how the proposals were prioritized. 


FDA observed that the Industry proposals did not seem to address stakeholder interests as identified in FDA’s monthly meetings with patient and consumer advocacy groups.  FDA indicated it would continue bringing stakeholders’ proposals to the negotiation meeting for consideration by both FDA and Industry. 


FDA asked Industry to confirm that its proposals were made in the context of a five year reauthorization.  Industry indicated that the duration of the program was not yet determined for their proposal and they could not yet commit to a five year program. 


Next Meeting


The next meeting will take place August 2, 2011.


Meeting End Time:  4:10 pm

Page Last Updated: 07/16/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English