21 CFR §803.10

1. (a)If you are a device user facility, you must submit reports (described in subpart C of this part), as follows:
   1. (1)Submit reports of individual adverse events no later than 10 work days after the day that you become aware of a reportable event:
      1. (i)Submit reports of device-related deaths to us and to the manufacturer, if known, or
      2. (ii)Submit reports of device-related serious injuries to the manufacturers or, if the manufacturer is unknown, submit reports to us.
   2. (2)Submit annual reports (described in § 803.33) to us.
2. (b)If you are an importer, you must submit reports (described in subpart D of this part), as follows:
   1. (1)Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable event:
      1. (i)Submit reports of device-related deaths or serious injuries to us and to the manufacturer or
      2. (ii)Submit reports of device-related malfunctions to the manufacturer.
   2. (2)[Reserved]
3. (c)If you are a manufacturer, you must submit reports (described in subpart E of this part) to us, as follows:
   1. (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. (2)Submit reports of individual adverse events no later than 5 work days after the day that you become aware of:
      1. (i)A reportable event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health or
      2. (ii)A reportable event for which we made a written request.
   3. (3)Submit supplemental reports if you obtain information that you did not submit in an initial report.