[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: 21CFR822.5]

[Page 167]
 
                        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. 822.5  How will I know if I must conduct postmarket surveillance?


    We will send you a letter (the postmarket surveillance order) 
notifying you of the requirement to conduct postmarket surveillance. 
Before we send the order, or as part of the order, we may require that 
you submit information about your device that will allow us better to 
define the scope of a surveillance order. We will specify the device(s) 
subject to the surveillance order and the reason that we are requiring 
postmarket surveillance of the device under section 522 of the act. We 
will also provide you with any general or specific guidance that is 
available to help you develop your plan for conducting postmarket 
surveillance.