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FDA’s MedWatch Plus

This article was originally published in The Gray Sheet

Executive Summary

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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