The Food & Drug Administration proposed new adverse event reporting rules for companies that make medical devices and other products.
The federal watchdog agency wants companies to submit the reports electronically, so it can more easily process, review and archive them.
David Buckles, director of the Division of Postmarket Surveillance at the Center for Devices and Radiological Health, said the proposed changes are aimed at getting safety information to the agency more quickly, meaning a faster reaction to potential threats to patient safety and public health.
The CDRH receives most mandatory medical device adverse event reports on paper, requiring them to be manually entered into the adverse events database it maintains, the “Manufacturer and User Facility Device Experience” database. IT’s a costly and time-consuming step that delays fast reviews of the information.
Under the new rules, companies would be given a choice of two electronic formats in which to submit the reports. Small manufacturers with a commensurate number of reports would use free “eSub” software provided by the agency. Larger outfits that are more frequent filers would be able to use a batch submission protocol, “based on a widely recognized informatics standard,” the agency said.