[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: 21CFR822.20]

[Page 170]
 
                        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 D_FDA Review and Action
 
Sec. 822.20  What are the consequences if I fail to submit a 
postmarket surveillance plan, my plan is disapproved and I fail 

to submit a new plan, or I fail to  conduct surveillance in 
accordance with my approved plan?

    The failure to have an approved postmarket surveillance plan or 
failure to conduct postmarket surveillance in accordance with the 
approved plan constitutes failure to comply with section 522 of the act. 
Your failure would be a prohibited act under section 301(q)(1)(C) of the 
act, and your device would be misbranded under section 502(t)(3) of the 
act. We have the authority to initiate actions against products that are 
adulterated or misbranded, and against persons who commit prohibited 
acts. Adulterated or misbranded devices can be seized. Persons who 
commit prohibited acts can be enjoined from committing such acts, 
required to pay civil money penalties, or prosecuted.