[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: 21CFR822.15]

[Page 160-161]
 
                        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. 822.15  How long must I conduct postmarket surveillance of my device?

    The length of postmarket surveillance will depend on the postmarket 
surveillance question identified in our order. We may order prospective 
surveillance for a period up to 36 months; longer periods require your 
agreement. If we believe that a prospective period of greater than 36 
months is necessary to address the surveillance question, and you do not 
agree, we will use the

[[Page 161]]

Medical Devices Dispute Resolution Panel to resolve the matter. You may 
obtain guidance regarding dispute resolution procedures from the Center 
for Devices and Radiological Health's (CDRH) Web site (www.fda.gov/cdrh/
resolvingdisputes/ombudsman.html) and from the CDRH Facts-on-Demand 
system (800-899-0381 or 301-827-0111, document number 1121). The 36-
month period refers to the surveillance period, not the length of time 
from the issuance of the order.