[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR803.13]



[Page 45]

 

                        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.