CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 803—MEDICAL DEVICE REPORTING > SUBPART A—General Provisions (§803.1 to §803.19) > 803.13—Do I need to submit reports in English?

803.13—Do I need to submit reports in English?

(a) Yes. You must submit all written or electronic equivalent reports required by this part in English.
(b) If you submit any reports required by this part in an electronic medium, that submission must be done in accordance with § 803.14.