[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: 21CFR822.6]

[Page 159]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 822--POSTMARKET SURVEILLANCE--Table of Contents
 
                         Subpart B--Notification
 
Sec. 822.6  When will you notify me that I am required to conduct postmarket surveillance?

    We will notify you as soon as we have determined that postmarket 
surveillance of your device is necessary, based on the identification of 
a surveillance question. This may occur during the review of a marketing 
application for your device, as your device goes to market, or after 
your device has been marketed for a period of time.