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Medical Devices

Minutes From Negotiation Meeting on MDUFA III Reauthorization, January 5, 2012

FDA - Industry MDUFA III Reauthorization Meeting
January 5, 2012, 9:15 am - 11:30 am
FDA Switzer Building, Washington, DC
Room 1007


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)
Elizabeth Hillebrenner CDRH
Toby Lowe CDRH
David Miller Office of Financial Management (OFM)
Thinh Nguyen OC
Tracy Phillips CDRH
Don St. Pierre CDRH
Francisco Vicenty CDRH
Ruth Watson Office of Legislation (OL)
Barbara Zimmerman CDRH
Jen Bowman American Clinical Laboratories Association
David Fisher Medical Imaging Technology Alliance
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
Joseph Levitt Hogan Lovells US LLP (representing AdvaMed)
John Manthei Latham and Watkins (representing MDMA)
James Ruger Quest Diagnostics (representing ACLA)
Janet Trunzo Advanced Medical Technology Association

Meeting Start Time: 9:15 am

Industry presented a counter-proposal to FDA’s December 22, 2011 proposal delivered to Industry via e-mail. FDA’s December 22, 2011 proposal was provided as an update to the proposal offered during the December 13, 2011 negotiation meeting, and incorporated revised financial assumptions based on newly available FY 2011 actual cost data. FDA’s December 22, 2011 proposal reflected a five-year “floor” cost of $636 million, prior to an increase if performance criteria are met by a mid-point in the program, and prior to any adjustments for inflation, workload, or budget authority appropriations.

Industry explained that, compared to Industry’s previous proposals, their counter-proposal reflects an increase in resources for FDA as well as modifications to the draft Commitment Letter intended to ease its burden on FDA. Industry noted they purposely focussed their modifications on Pre-Submission goals rather than other aspects of the draft Commitment Letter, as they believe this should offer cost savings and is an area which Industry is most amenable to altering.

Industry proposed modifications to the draft Commitment Letter with a stated goal of lowering FDA’s resource burdens. Industry proposed lengthening the previously proposed quantitative goals associated with Pre-Submission meetings so that they align with current practice. Additionally, Industry proposed narrowing the definition of a Pre-Submission to a formal written request from an applicant that includes specific questions concerning discrete issues required to be addressed in an IDE or marketing application under consideration by the applicant (e.g., pre-clinical and clinical testing protocols; data requirements). Industry also provided examples of what would not be considered within this new definition. Industry also proposed changes to the definition of substantive interactions to be clear that they consist of a communication to update the applicant of the status of the review, next steps in the review process, and any deficiencies identified during the review, or a statement that FDA has not identified any deficiencies in the initial submission review. Industry also proposed a statement that interactive review will be used to communicate and resolve minor issues during the time leading to the issuance of a substantive interaction as appropriate according to the guidance. FDA noted that in cases where major deficiencies exist, it is not always efficient to postpone a hold letter so that minor issues can first be resolved interactively. There was discussion of the definition and best practices. Industry indicated their willingness to consider a counter-proposal from FDA based on the discussion.

Industry offered a $500 million base for the five year program. Additional funding would be provided based on an annual adjustment based on actual inflation. Industry proposed an annual cap of 3% and floor of 0% for the inflation adjustment. FDA noted that their December 22, 2012 e-mail update to their December 13, 2012 proposal included a formula for adjusting inflation with 60% weighted towards the three year rolling average of payroll costs and benefits and 40% weighted towards the CPI-U for the Washington, DC area. Industry stated that additional discussion on the specific inflation adjuster formula would be necessary. Industry also noted that their proposal does not include adjusters for increases in workload or shortfalls in budget authority appropriations.

Under the proposal, further additional funding would also be provided if FDA were to meet the following five specific criteria in an interim performance assessment: FDA must meet or be on track to meet 510(k) and original PMA MDUFA II goals for the FY2012 receipt cohort; 92% of 510(k)s received in the first six months of MDUFA III must receive an FDA decision within 90 FDA days; the average total time to decision for 510(k)s must show a trend of improvement in monthly decision cohorts and the average total time to decision for 510(k)s received in the first six months of MDUFA III must be ≤123 days; the 510(k) substantive interactions goals must be met for the full FY2013 receipt cohort and first half of the FY2014 receipt cohort; and, the PMA and panel-track supplement substantive interactions goals must be met for the full FY2013 receipt cohort and first half of the FY2014 receipt cohort. If all five criteria are met based on an assessment as of March 31, 2014, an additional $50 million would be provided over the last three years of MDUFA III. Industry noted that their proposal limits the interim performance criteria to 510(k)s and original PMAs because these are of greatest importance. FDA noted two elements of Industry’s proposal that may be difficult to assess. First, the receipt cohorts from the first six months of FY2013 may not be complete by the March 31, 2014 analysis. Second, the criteria for a trend of monthly improvements in average total time to decision for 510(k) would need to be written more clearly and objectively.

FDA recognized that Industry’s proposal represented an increase in resources over their previous proposal, but noted that a significant gap remained between Industry’s proposal and the resources FDA believes are needed to accomplish the commitments outlined in the draft commitment letter. FDA stated they would review Industry’s proposal in more detail and provide further feedback as soon as possible.

Meeting End Time: 11:30 am

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