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Electronic Adverse Event Reporting Will Soon Be Mandatory, FDA Says

This article was originally published in The Gray Sheet

Executive Summary

FDA is urging device manufacturers to voluntarily adopt the agency's electronic Medical Device Reporting (eMDR) process in anticipation of being required to do so as early as next spring

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FDA To Release e-Adverse Event System Iteratively, Starting With Foods

FDA's electronic "rational questionnaire" adverse event data collection system will initially only accept reportable food events, then expand to veterinary drug events, followed by reports for devices, drugs and other products regulated by the agency, according to a May 20 Federal Register 1notice

FDA To Release e-Adverse Event System Iteratively, Starting With Foods

FDA's electronic "rational questionnaire" adverse event data collection system will initially only accept reportable food events, then expand to veterinary drug events, followed by reports for devices, drugs and other products regulated by the agency, according to a May 20 Federal Register 1notice

FDA’s MedWatch Plus

Agency expects all of its centers to be using the still-in-development MedWatch Plus product safety information reporting system by fiscal 2011, according to an Oct. 23 Federal Register 1notice. The all- electronic system will replace the largely paper-based processes now in place. It will incorporate a "rationale questionnaire" allowing consumers to enter simple information, but will also accommodate and prompt more complex mandatory entries from manufacturers, FDA says. The system will interact with FDA's Gateway electronic submissions portal, which powers CDRH's soon-to-be-mandatory electronic Medical Device Reporting system (2"The Gray Sheet" Oct. 1, 2007, p. 19)

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