GroundRules
21 CFR 803.13: Do I need to submit reports in English?
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 803—MEDICAL DEVICE REPORTING
- Subpart A—General Provisions
Yes. You must submit all reports required by this part in English.
Collected 2026-08-27T02:24:47Z. Source file · JSON