# 21 C.F.R. § 803.11 (2026): What form should I use to submit reports of individual adverse events and where do I obtain these forms?

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_11

## Section

- **Citation:** 21 C.F.R. § 803.11 (2026)
- **Heading:** What form should I use to submit reports of individual adverse events and where do I obtain these forms?
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 803: MEDICAL DEVICE REPORTING / Subpart A: General Provisions / § 803.11: § 803.11   What form should I use to submit reports of individual adverse events and where do I obtain these forms?

## Text

(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) and § 803.20, unless granted an exemption under § 803.19.
(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) and § 803.20.
(d) Form FDA 3500A is available on the internet at
https://www.accessdata.fda.gov/scripts/medwatch/index.cfm.
[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015; 85 FR 18441, Apr. 2, 2020]

## Nearby sections

- [21 C.F.R. § 803.1 (2026) § 803.1   What does this part cover?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_1.md)
- [21 C.F.R. § 803.3 (2026) § 803.3   How does FDA define the terms used in this part?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_3.md)
- [21 C.F.R. § 803.9 (2026) § 803.9   What information from the reports do we disclose to the public?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_9.md)
- [21 C.F.R. § 803.10 (2026) § 803.10   Generally, what are the reporting requirements that apply to me?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_10.md)
- [21 C.F.R. § 803.11 (2026) § 803.11   What form should I use to submit reports of individual adverse events and where do I obtain these forms?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_11.md)
- [21 C.F.R. § 803.12 (2026) § 803.12   How do I submit initial and supplemental or followup reports?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_12.md)
- [21 C.F.R. § 803.13 (2026) § 803.13   Do I need to submit reports in English?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_13.md)
- [21 C.F.R. § 803.15 (2026) § 803.15   How will I know if you require more information about my medical device report?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_15.md)
- [21 C.F.R. § 803.16 (2026) § 803.16   When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_16.md)
- [21 C.F.R. § 803.17 (2026) § 803.17   What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_17.md)
- [21 C.F.R. § 803.18 (2026) § 803.18   What are the requirements for establishing and maintaining MDR files or records that apply to me?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_18.md)
- [21 C.F.R. § 803.19 (2026) § 803.19   Are there exemptions, variances, or alternative forms of adverse event reporting requirements?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_19.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_11. Check the current official text before relying on it. Not legal advice.