FDA's e-adverse event system will eventually apply to devices

FDA's electronic "rational questionnaire" adverse event data collection system will initially only accept reportable food events, and 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 notice. All sections of FDA should be using the system by 2011, the agency says in the notice. The goal of the questionnaire is to offer a user-friendly, guided approach to anyone submitting an adverse event report to FDA's MedWatch Plus electronic portal, which still is in development. Mandatory event reporters, such as device companies, will continue to have the option of relying on the current electronic gateway-to-gateway data collection system ("The Silver Sheet" November 2008)