[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.13]

[Page 44]
 
                        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  English reporting requirement.

    (a) All reports required in this part which are submitted in writing 
or electronic equivalent shall be submitted to FDA in English.
    (b) All reports required in this part which are submitted on an 
electronic medium shall be submitted to FDA in a manner consistent with 
Sec. 803.14.