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Medical Devices

Minutes From Negotiation Meeting on MDUFA III Reauthorization, February 16, 2012

FDA – Industry MDUFA III Reauthorization Meeting
February 16, 2012, 4:00 pm – 5:15 pm

To discuss MDUFA III reauthorization.


Malcolm BertoniOffice of the Commissioner (OC)
Nathan Brown           Office of Chief Counsel (OCC)
Kate CookCenter for Biologics Evaluation and Research (CBER)
Elizabeth HillebrennerCenter for Devices and Radiological Health (CDRH)
Toby LoweCDRH
Thinh NguyenOC
Don St. PierreCDRH
Nicole WolanskiCDRH
Barbara ZimmermanCDRH
Hans BeinkeSiemens (representing MITA)
Jen BowmanAmerican Clinical Laboratories Association
Brian ConnellMedical Imaging Technology Alliance
John FordAbbott Laboratories (representing AdvaMed)
Elisabeth GeorgePhillips (representing (MITA)
Donald HortonLaboratory Corporation of America Holdings (representing ACLA)
Joseph LevittHogan Lovells US LLP (representing AdvaMed)
Mark LeaheyMedical Device Manufacturers Association
Alan MertzAmerican Clinical Laboratories Association
James RugerQuest Diagnostics (representing ACLA)
Patricia ShraderMedtronic  (representing AdvaMed)
Janet TrunzoAdvanced Medical Technology Association

Meeting Start Time: 4:00pm

Industry1 provided feedback on FDA’s proposed legislative language.  Industry suggested modification of the definition of an “establishment subject to registration fee.”  Upon discussion, both parties agreed to a revised definition.

Industry suggested revisions to the fee adjustment provision.  FDA noted that their proposal called for adjustments to the registration fees based on both facility and submission quantities.  The goal of FDA’s approach is to achieve each annual targeted collection amount while minimizing any potential under- or over-collections that could result from inaccurate estimates of submission and facility quantities.  FDA explained that this is important given that any under-collections result in lost revenues that cannot be made up later, and any over-collections would essentially be lost by the device program due to  scoring and appropriations rules governing user fee overcollections, despite how the fee offset provision was intended to work.  Industry indicated that FDA’s proposed adjustment method required further discussion. 

FDA presented additional assurances to address Industry’s concerns regarding FDA’s February 14, 2012 proposal for a discretionary fee waiver provision intended to address Laboratory Developed Tests (LDTs).  Specifically, FDA stated that the fee waiver provision would not alter their commitment to meet performance goals agreed upon in the draft Commitment Letter.  FDA also indicated their agreement with Industry’s suggestion to exclude from performance goal cohorts any submission for which FDA waived a fee under this discretionary waiver provision, as this is consistent with the fee for performance concept underlying the user fee program.  FDA agreed to include the above concepts in the Commitment Letter.  Finally, FDA agreed with Industry’s suggestion of a cap on the total value of waivers that could be granted under this provision.  Based on Dr. Shuren’s February 15, 2012 testimony to the House of Representatives Energy and Commerce Committee in which he estimated the cost of a change in FDA’s policy regarding regulation of LDTs at less than $3 million per year, FDA proposed a $15 million cap on total value of waivers granted under this provision for the  five years of MDUFA III.  The waiver provision and cap on the total value of waivers granted under this provision would be outlined in the legislative language. 

ACLA agreed to FDA’s proposed assurances.  Industry asked ACLA if they would continue to lobby for a statutory exclusion from FDA jurisdiction for LDTs should the discretionary waiver provision be agreed upon in MDUFA III.  ACLA replied that such legislation is outside the scope of MDUFA, but stated they would not lobby Congress on how user fees would be applied.  Industry asked ACLA if they intend to actively oppose MDUFA III if the agreement did not include a discretionary fee waiver provision.  ACLA stated that they would support the agreement with a waiver and associated provisions as described by FDA.

Industry proposed an additional statement in the Commitment Letter indicating that any application subject to a fee waiver and not subject to performance goals shall be reviewed as resources permit.  FDA indicated that the phrase “as resources permit” does not imply that all such submissions “go to the back of the line.”  Rather, this phrase “as resources permit” is used throughout the draft Commitment Letter in areas where resources were not specifically dedicated.  FDA noted that they have considered the workload that a new LDT policy might entail throughout negotiations.  FDA stated that they will manage the program, which will still be funded mostly by Budget Authority appropriations, in a manner they believe is in the best interest of public health.

Industry proposed that FDA consider exemptions for low risk medical devices within one year of enactment and work with the device industry to develop a transitional approach for the regulation of emerging diagnostics.

Industry proposed legislative language indicating the discretionary fee waiver provision sunsets at the end of MDUFA III.

Industry stated that they did not agree with FDA’s proposed $15 million cap on discretionary waivers.

Next Meeting

The next meeting will take place February 17, 2012.

Meeting End Time:  5:15pm


1For purposes of these minutes only, the term industry means AdvaMed, MITA, and MDMA and does not include ACLA unless specifically noted.

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