GLOSSARYUS
Medical Device Report
A report to the FDA from a manufacturer, importer, or device user facility. The report is required when a device may have caused or contributed to a death or serious injury. A malfunction that would likely cause one if it recurred also triggers the report. Part 803 sets the report types and deadlines.
Avoid This Mistake
The trigger is information that reasonably suggests the event, not a confirmed cause. A manufacturer must report within 30 calendar days of becoming aware of such information from any source.