[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: 21CFR801.16]

[Page 16]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 801--LABELING--Table of Contents
 
                 Subpart A--General Labeling Provisions
 
Sec. 801.16  Medical devices; Spanish-language version of certain required statements.

    If devices restricted to prescription use only are labeled solely in 
Spanish for distribution in the Commonwealth of Puerto Rico where 
Spanish is the predominant language, such labeling is authorized under 
Sec. 801.15(c).

Subpart B [Reserved]