# 21 C.F.R. § 803.13 (2026): Do I need to submit reports in English?

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_13

## Section

- **Citation:** 21 C.F.R. § 803.13 (2026)
- **Heading:** Do I need to submit reports in English?
- **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 / § 803.13: § 803.13   Do I need to submit reports in English?

## Text

Yes. You must submit all reports required by this part in English.

## 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_13. Check the current official text before relying on it. Not legal advice.