The Food and Drug Administration is seeking comments no later
than April 16 on the proposed extension of an information collection associated
with importer, manufacturer, user facility and distributor reporting concerning
medical devices.
FDA regulations require user facilities to report to the device
manufacturer and FDA incidents where a medical device caused or contributed to
a death or serious injury. Additionally, user facilities are required to
annually submit via form FDA 3419 the number and summary of adverse events
reported during the calendar year.
Manufacturers of medical devices must report to FDA when they
become aware of information indicating that one of their devices may have
caused or contributed to death or serious injury or has malfunctioned in such a
way that should the malfunction recur it would be likely to cause or contribute
to a death or serious injury. Device importers report deaths and serious
injuries to FDA and manufacturers. Importers report malfunctions only to the
manufacturers, unless they are unknown, in which case the reports are sent to
FDA.
Click here for FDA notice
Click here for FDA notice
