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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR803.13]
See Related Information on Do I need to submit reports in English? in CDRH databases



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

Sec. 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.

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