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Home
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Issues & Advocacy
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FDA & Regulatory
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Science & Tech
> Medical Device User Fee & Modernization Act
Medical Device User Fee & Modernization Act
Information
06/12/07
AdvaMed's written testimony to the House Energy & Commerce Subcommittee on Health concerning reauthorization of the Medical Device User Fee & Modernization Act, etc.
02/25/05
AdvaMed Comments on High NSE Rate and Need to Review Validation Data for All Reprocessed Single-Use Devices
(pdf)
12/22/04
AdvaMed Responds to FDA Word on User Fees
11/18/04
AdvaMed Presentations at FDA Stakeholders 2nd Annual Meeting on Medical Device User Fee and Modernization Act (MDUFMA) Implementation
09/30/04
AdvaMed's comments to CDRH on adverse events associated with reprocessed single-use devices (heart positioners and stabilizers)
(pdf)
08/14/04
FDA Commissioner's Goal Explanation to Reduce Review Times (Members Only)
(pdf)
08/14/04
Summary Information on Baseline Years 1999-2001 (Members Only)
(pdf)
06/22/04
Comments on “Report to Congress on Timeliness and Effectiveness of Device Premarket: Reviews by Centers other than the Centers for Devices and Radiological Health.” (CBER REPORT)
(pdf)
Resources
Why User Fees Are Necessary
Frequently Asked Questions About User Fees
(pdf)
PDUFA: A Win for Patients