[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: 21CFR801.116]

[Page 21]
 
                        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 D--Exemptions From Adequate Directions for Use
 
Sec. 801.116  Medical devices having commonly known directions.

    A device shall be exempt from section 502(f)(1) of the act insofar 
as adequate directions for common uses thereof are known to the ordinary 
individual.