[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.13]

[Page 50]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 803_MEDICAL DEVICE REPORTING--Table of Contents
 
                      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 Sec.  803.14.