[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: 21CFR822.4]

[Page 158-159]
 
                        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 A--General Provisions
 
Sec. 822.4  Does this part apply to me?

    If we have ordered you to conduct postmarket surveillance of a 
medical device under section 522 of the act, this part applies to you. 
We have the authority to order postmarket surveillance of any class II 
or class III medical device, including a device reviewed under the 
licensing provisions of section 351 of the Public Health Service Act, 
that meets 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

[[Page 159]]

    (c) The device is intended to be used to support or sustain life and 
to be used outside a user facility.