Transcription of Draft Recommendations Report by the Heart …
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Draft Recommendations Report by the Heart …
Embargoed until April 26, 2006 Draft Recommendations Report by the Heart Rhythm Society Task Force on Device Performance Policies and GuidelinesDRAFTA p r i l 2 6 , 2 0 0 6 Heart Rhythm Society Draft Recommendations ReportTABLE OF CONTENTSS ummary of Recommendations ..4 Introduction ..7 Device Performance and 8 Communication of Device Performance ..8 Table 1 ..10 Table 2 ..11 Surveillance ..12 Analysis of Data Roles of Industry, FDA, and Physicians ..14 Terminology and Threshold for Activation of Device Recalls and Advisory Notices ..15 Table 3 ..16 Communication After Device Malfunction is Identified ..16 Physician Device Advisory Notification ..18 Patient Notification Letter.
Recommendations The Heart Rhythm Society Recommendations FROM THE TASK FORCE ON DEVICE PERFORMANCE POLICIES AND GUIDELINES Heart Rhythm Society Draft Recommendations Report
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