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“Passive” Adverse Event Data Inadequate, Say FDA/HRS Meeting Panelists

This article was originally published in The Gray Sheet

Executive Summary

FDA must expand its "enhanced" adverse event reporting system and improve "passive" surveillance in order to detect rare device malfunctions, said panelists at the Policy Conference on Pacemaker and Implantable Cardioverter Defibrillator Performance in Washington, D.C. Sept. 16

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