803.10—Generally, what are the reporting requirements that apply to me?
(a)
If you are a device user facility, you must submit reports (described in subpart C of this part), as follows:
(1)
Submit reports of individual adverse events no later than 10 work days after the day that you become aware of a reportable event:
(ii)
Submit reports of device-related serious injuries to the manufacturers or, if the manufacturer is unknown, submit reports to us.
(b)
If you are an importer, you must submit reports (described in subpart D of this part), as follows:
(1)
Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable event:
(c)
If you are a manufacturer, you must submit reports (described in subpart E of this part) to us, as follows:
(1)
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.
(2)
Submit reports of individual adverse events no later than 5 work days after the day that you become aware of:
(i)
A reportable event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health, or
(3)
Submit supplemental reports if you obtain information that you did not submit in an initial report.