---
kind: "section"
citation: "21 C.F.R. § 803.10"
title: "21"
number: "803.10"
heading: "Generally, what are the reporting requirements that apply to me?"
url: "https://uscodex.org/cfr/21/803.10"
---

# §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](/cfr/21/subpartC.md) 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](/cfr/21/803.33.md)) to us.
- (b) If you are an importer, you must submit reports (described in [subpart D](/cfr/21/subpartD.md) 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](/cfr/21/subpartE.md) 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.**

## Notes

### Authority

Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

### Source

Source: 79 FR 8846, Feb. 14, 2014, unless otherwise noted.