If you are a device user facility, you must submit reports (described in subpart C of this part), as follows:
Submit reports of individual adverse events no later than 10 work days after the day that you become aware of a reportable event:
Submit reports of device-related deaths to us and to the manufacturer, if known, or
Submit reports of device-related serious injuries to the manufacturers or, if the manufacturer is unknown, submit reports to us.
Submit annual reports (described in § 803.33) to us.
If you are an importer, you must submit reports (described in subpart D of this part), as follows:
Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable event:
Submit reports of device-related deaths or serious injuries to us and to the manufacturer or
Submit reports of device-related malfunctions to the manufacturer.
[Reserved]
If you are a manufacturer, you must submit reports (described in subpart E of this part) to us, as follows:
Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable death, serious injury, or malfunction.
Submit reports of individual adverse events no later than 5 work days after the day that you become aware of:
A reportable event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health or
A reportable event for which we made a written request.
Submit supplemental reports if you obtain information that you did not submit in an initial report.
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