21 CFR § 803.13 - Do I need to submit reports in English?

---
identifier: "/us/cfr/t21/s803.13"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 803.13 - Do I need to submit reports in English?"
title_number: 21
title_name: "Food and Drugs"
section_number: "803.13"
section_name: "Do I need to submit reports in English?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "803"
part_name: "MEDICAL DEVICE REPORTING"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 352, 360, 360i, 360j, 371, 374."
regulatory_source: "79 FR 8846, Feb. 14, 2014, unless otherwise noted."
cfr_part: "803"
---