---
kind: "section"
citation: "21 C.F.R. § 803.30"
title: "21"
number: "803.30"
heading: "If I am a user facility, what reporting requirements apply to me?"
url: "https://uscodex.org/cfr/21/803.30"
---

# §803.30. If I am a user facility, what reporting requirements apply to me?

- (a) You must submit reports to the manufacturer or to us, or both, as specified in paragraphs [(a)(1)](#a-1) and [(a)(2)](#a-2) of this section as follows:
  - (1) **Reports of death.** You must submit a report to us as soon as practicable but no more than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to the death of a patient of your facility. You must also submit the report to the device manufacturer, if known. You must submit the information required by [§ 803.32](/cfr/21/803.32.md). Reports sent to the Agency must be submitted in accordance with the requirements of [§ 803.12(b)](/cfr/21/803.12.md?p=b).
  - (2) **Reports of serious injury.** You must submit a report to the manufacturer of the device no later than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of your facility. If the manufacturer is not known, you must submit the report to us. You must report information required by [§ 803.32](/cfr/21/803.32.md). Reports sent to the Agency must be submitted in accordance with the requirements of [§ 803.12 (b)](/cfr/21/803.12.md?p=b).
- (b) **What information does FDA consider “reasonably known” to me?** You must submit all information required in this subpart C that is reasonably known to you. This information includes information found in documents that you possess and any information that becomes available as a result of reasonable followup within your facility. You are not required to evaluate or investigate the event by obtaining or evaluating information that you do not reasonably know.

## Notes

### Authority

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

### Source

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