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U.S. Department of Health and Human Services

Medical Devices

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Minutes From Negotiation Meeting on MDUFA III Reauthorization, February 10, 2012

FDA – Industry MDUFA III Reauthorization Meeting
February 10, 2012, 1:00 pm – 1:45 pm
Teleconference

Purpose
To discuss MDUFA III reauthorization.

Participants

FDA
Malcolm Bertoni Office of the Commissioner (OC)
Nathan Brown            Office of Chief Counsel (OCC)
Kate Cook Center for Biologics Evaluation and Research (CBER)
Christy Foreman Center for Devices and Radiological Health (CDRH)
Elizabeth Hillebrenner CDRH
Toby Lowe CDRH
Don St. Pierre CDRH
Francisco Vicenty CDRH
Nicole Wolanski CDRH
Barbara Zimmerman CDRH
Industry
Jen Bowman American Clinical Laboratories Association
Brian Connell Medical Imaging Technology Alliance
Mark Leahey Medical Device Manufacturers Association
James Ruger Quest Diagnostics (representing ACLA)
Janet Trunzo Advanced Medical Technology Association

Meeting Start Time:  1:00pm

Industry presented a proposal for the MDUFA III fee structure.  Given that the actual PMA fee for fiscal year 2012 is lower then expected due to the offset, Industry proposed setting the PMA fee at a level that avoids a steep increase in relation to FY 2012 actual fees.  Industry proposed increasing 510(k) fees from 1.84% to 2.0% of PMA fees.  Industry’s proposed registration fee assumes the elimination of exemptions for facility registrations.

Industry noted this proposal includes collections that exceed estimated expenditures in fiscal years 2013 and 2014, which balance out in the remaining three years during which expenditures exceed collections; during these years, carryover balances are used to make up the year-by-year difference. 

FDA indicated that the general approach proposed by Industry is reasonable.  FDA will evaluate the proposal in detail and provide feedback promptly. 

The parties discussed the Agency’s lack of authority to spend the MDUFA II fee over-collections (due to lack of appropriation), despite lowering the fees in FY 2012 to offset the over-collections.  The parties agreed that this outcome was inconsistent with Congressional intent and created a problem that continues into FY 2012.  One goal of the MDUFA III fee structure is to minimize over-collections that result in a high offset balance.  Due to uncertainty regarding how elimination of exemptions may impact the number of facility registrations, FDA suggested allowing the fees to be adjusted annually to better estimate the targeted fee collections for each year.  

Next Meeting

The next meeting will take place February 14, 2012.

Meeting End Time:  1:45 pm

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