Adverse Event Reporting For Medical Devices

摘要

Adverse event reporting enables FDA to take corrective action on problem devices and to prevent injury and death by alerting the public when potentially hazardous devices are discovered. Within FDA, the Center for Devices and Radiological Health (CDRH) is responsible for regulating medical devices. Regulations require device manufacturers to report to FDA (1) within 30 calendar days of acquiring information that reasonably suggests one of their devices may have caused or contributed to a death, serious injury, or malfunction and (2) within 5 working days if an event requires action other than routine maintenance or service to prevent a public health issue.