[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR814.80]

[Page 138]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 814_PREMARKET APPROVAL OF MEDICAL DEVICES--Table of Contents
 
                   Subpart E_Postapproval Requirements
 
Sec. 814.80  General.


    A device may not be manufactured, packaged, stored, labeled, 
distributed, or advertised in a manner that is inconsistent with any 
conditions to approval specified in the PMA approval order for the 
device.