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79 FR 8846, Feb. 14, 2014, unless otherwise noted.
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(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.
(2) [Reserved]
(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.