[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: 21CFR822.1]

[Page 157]
 
                        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 A--General Provisions
 
Sec. 822.1  What does this part cover?


    This part implements section 522 of the Federal Food, Drug, and 
Cosmetic Act (the act) by providing procedures and requirements for 
postmarket surveillance of class II and class III devices that meet any 
of the following criteria:
    (a) Failure of the device would be reasonably likely to have serious 
adverse health consequences;
    (b) The device is intended to be implanted in the human body for 
more than 1 year; or
    (c) The device is intended to be used outside a user facility to 
support or sustain life. If you fail to comply with requirements that we 
order under section 522 of the act and this part, your device is 
considered misbranded under section 502(t)(3) of the act and you are in 
violation of section 301(q)(1)(C) of the act.