Section 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:(i) Submit reports of device-related deaths to us and to the manufacturer, if known, or(ii) Submit reports of device-related serious injuries to the manufacturers or, if the manufacturer is unknown, submit reports to us.(2) Submit annual reports (described in § 803.33 ) 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:(i) Submit reports of device-related deaths or serious injuries to us and to the manufacturer or(ii) Submit reports of device-related malfunctions to the manufacturer.(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(ii) A reportable event for which we made a written request.(3) Submit supplemental reports if you obtain information that you did not submit in an initial report.