FDA electronic MDR reporting workshop scheduled for January 25, 1996.
This article was originally published in The Gray Sheet
Executive Summary
DEVICE ADVERSE EVENT ELECTRONIC REPORTING WORKSHOP SCHEDULED FOR JAN. 25 is designed to provide FDA with industry input on its plans to implement an electronic medical device reporting system in 1997. The session in Gaithersburg, Maryland will include presentations from FDA, industry, user facilities and electronic data interchange (EDI) vendors, as well as a "forum" for interested parties "to discuss their ideas, desires, and needs regarding electronic report submission," the agency says.