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Medical Devices

Minutes From Negotiation Meeting on MDUFA III Reauthorization, February 17, 2012

FDA – Industry MDUFA III Reauthorization Meeting
February 17, 2012, 2:30 pm – 3:00 pm

To discuss MDUFA III reauthorization.


Malcolm Bertoni Office of the Commissioner (OC)
Nathan Brown            Office of Chief Counsel (OCC)
Kate Cook Center for Biologics Evaluation and Research (CBER)
Elizabeth Hillebrenner Center for Devices and Radiological Health (CDRH)
Toby Lowe CDRH
Tracy Phillips CDRH
Don St. Pierre CDRH
Nicole Wolanski CDRH
Jen Bowman American Clinical Laboratories Association (ACLA)
Brian Connell Medical Imaging Technology Alliance
John Ford Abbott Laboratories (representing AdvaMed)
Donald Horton Laboratory Corporation of America Holdings (representing ACLA)
Joseph Levitt Hogan Lovells US LLP (representing AdvaMed)
Mark Leahey Medical Device Manufacturers Association
Alan Mertz ACLA
James Ruger Quest Diagnostics (representing ACLA)
Janet Trunzo Advanced Medical Technology Association

Meeting Start Time: 2:30pm

FDA proposed modifications to the draft Commitment Letter and legislative language to address concerns from Industry1

Commitment Letter
FDA revised the Commitment Letter to reflect that FDA will propose to exempt additional low risk medical devices from premarket notification by the end of 2013, consistent with FDA’s ongoing review and risk-based approach to regulating medical devices.  Within two years of such proposal, FDA intends to issue a final rule exempting additional low risk medical devices from premarket notification.  FDA also proposed to work with industry to develop a transitional In Vitro Diagnostics (IVD) approach for the regulation of emerging diagnostics.

FDA modified the Commitment Letter to indicate that the independent analysis of the review process will include the impact of the review of laboratory developed tests on the review process.

FDA added a new section to the Commitment Letter describing the discretionary fee waiver provision that FDA proposed in the legislative language.  FDA further noted in the Commitment Letter that, notwithstanding any fee waivers or reductions granted by the Agency under this discretionary authority, FDA remains committed to meeting the goals described in the letter.  Any application subject to a fee waiver or reduction under the discretionary authority shall not be subject to the goals specified in the letter and shall be reviewed by the Agency as resources permit.  The discretionary authority will expire at the end of MDUFA III.  Also, FDA’s commitment for routine reporting will include the number of discretionary fee waivers or reductions granted by submission type.

Legislative Language

FDA proposed a 2% annual cap for the discretionary fee waiver provision, based on the total annual fee revenues, and revised the language to clarify that the discretionary fee waiver provision will terminate on October 1, 2017.

With the changes outlined above, AdvaMed, MDMA, MITA, ACLA, and FDA all agreed to the draft Commitment Letter and draft legislative language. 

Meeting End Time:  3:00pm


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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