§ 803.10. Generally, what are the reporting requirements that apply to me?
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/us/cfr/t21/s§ 803.10·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.
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§ 803.10
Generally, what are the reporting requirements that apply to me?
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