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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)


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