Frix
Try Donna

§ 803.13 Do I need to submit reports in English?

FederalRegulations

Ask Donna

How this section applies to your facts.

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?

This text was captured on Aug 14, 2026. It is a snapshot, not a live feed, so check the official code before relying on it.

Text

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

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

A word about cookies

We need a few to keep you signed in and the library working. The rest help us see which pages people use and where they get stuck. They stay off unless you say yes.