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Medical Devices

Minutes From Negotiation Meeting on MDUFA III Reauthorization, February 8, 2012

FDA – Industry MDUFA III Reauthorization Meeting
February 8, 2012, 3:00 pm – 3:45 pm

To discuss MDUFA III reauthorization.


Malcolm BertoniOffice of the Commissioner (OC)
Nathan BrownOffice of Chief Counsel (OCC)
Kate CookCenter for Biologics Evaluation and Research (CBER)
Christy ForemanCenter for Devices and Radiological Health (CDRH)
Elizabeth HillebrennerCDRH
Toby LoweCDRH
David MillerOFO
Tracy PhillipsCDRH
Don St. PierreCDRH
Francisco VicentyCDRH
Nicole WolanskiCDRH
Barbara ZimmermanCDRH
Jen BowmanAmerican Clinical Laboratories Association
Brian ConnellMedical Imaging Technology Alliance
Donald HortonLaboratory Corporation of America Holdings (representing ACLA)
Tamima ItaniBoston Scientific (representing MDMA)
Mark LeaheyMedical Device Manufacturers Association
Lindsay MorrisMedical Imaging Technology Alliance
James RugerQuest Diagnostics (representing ACLA)
Janet TrunzoAdvanced Medical Technology Association

Meeting Start Time:  3:00pm

Industry responded to some elements of FDA’s proposals regarding fee structure. 

Industry agreed with FDA’s December 22, 2011 update to their December 13, 2011 proposal to calculate an annual inflation adjustment with 60% weighted towards the three-year rolling average of payroll costs and benefits, and 40% weighted towards the three-year rolling average CPI-U for the Washington, DC area. 

FDA noted that under the sample fee structure the Agency provided, inflation was absorbed entirely by establishment registration fees, preserving predictability of submission fees.  Industry stated they would like the inflation adjustments to be applied across the board to all application types as well as registration fees, but they were not ready to propose a specific fee structure.  FDA indicated their willingness to accept a fee structure that would work best for Industry.

Industry asked if collections must align with expenditures for each year in the MDUFA III spend plan.  FDA replied that higher collections versus expenditures in earlier years would be acceptable; however, lower collections versus expenditures in earlier years would potentially present a cash flow problem.  FDA also noted that higher collections versus expenditures in earlier years would necessarily result in lower collections versus expenditures in later years.  Both parties agreed to use FY2017 expenditures as a baseline for MDUFA IV, regardless of the spend plan ultimately agreed upon.

Industry noted MDUFA is intended to provide user fees that are additive to Budget Authority (BA) appropriations.  As such, Industry proposed including and updating the 2002 appropriations trigger to a level that reflects more recent BA appropriations for the devices and radiological health program. 

Previously, the parties had discussed the potential for expanding the base of registration and listing fee payers by eliminating some of the current exemptions.  Industry proposed that all establishments that are required to register should pay the registration fee.   

Industry will propose a fee structure and FDA will then propose statutory language.

Next Meeting

The next meeting will take place February 10, 2012.

Meeting End Time:  3:45 pm

Page Last Updated: 07/16/2014
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