DEVICE MALFUNCTION REPORT BACKLOG OF 15,000-20,000
This article was originally published in The Gray Sheet
Executive Summary
DEVICE MALFUNCTION REPORT BACKLOG OF 15,000-20,000 reports requiring database entry continues to grow, according to FDAers. The backlog represents several months of incoming malfunction and follow-up reports that have not yet been entered into the Center for Devices and Radiological Health's medical device reporting database; staff estimate about 4,000 such reports are received each month.