21 C.F.R. § 803.10

2020-08-17
§ 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.

(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.