Yes. You must submit all reports required by this part in English.
21 CFR Part 803 · Medical Device Reporting
§ 803.13 Do I need to submit reports in English?
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
FDA guidance that cites § 803.13
- Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration Staff 8 Nov 2016
- Medical Device Reporting for User Facilities 1 Apr 1996
Amendment history
Federal Register documents that created or amended this section.
- 79 FR 8846 14 Feb 2014