---
kind: "section"
citation: "21 C.F.R. § 803.11"
title: "21"
number: "803.11"
heading: "What form should I use to submit reports of individual adverse events and where do I obtain these forms?"
url: "https://uscodex.org/cfr/21/803.11"
---

# §803.11. What form should I use to submit reports of individual adverse events and where do I obtain these forms?

- (a) If you are a manufacturer or importer, you must submit reports of individual adverse events to FDA in an electronic format in accordance with [§ 803.12(a)](/cfr/21/803.12.md?p=a) and [§ 803.20](/cfr/21/803.20.md), unless granted an exemption under [§ 803.19](/cfr/21/803.19.md).
- (b) Importer reports submitted to device manufacturers may be in paper format or an electronic format that includes all required data fields to ensure that the manufacturer has all required information.
- (c) If you are a user facility, you must submit reports of individual adverse events in accordance with [§ 803.12(b)](/cfr/21/803.12.md?p=b) and [§ 803.20](/cfr/21/803.20.md).
- (d) **Form FDA 3500A is available on the internet at <I>https—** //www.accessdata.fda.gov/scripts/medwatch/index.cfm.

## Notes

### Amendments

[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015; 85 FR 18441, Apr. 2, 2020]

### Authority

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

### Source

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

### Amendments

[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015; 85 FR 18441, Apr. 2, 2020]