[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: 21CFR822.11]

[Page 168]
 
                        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 C_Postmarket Surveillance Plan
 
Sec. 822.11  What should I consider when designing my plan to conduct
postmarket surveillance?

    You must design your surveillance to address the postmarket 
surveillance question identified in the order you received. You should 
consider what, if any, patient protection measures should be 
incorporated into your plan. You should also consider the function, 
operating characteristics, and intended use of your device when 
designing a surveillance approach.

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