[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: 21CFR822.15]

[Page 169]
 
                        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 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/ombudsman/). The 36-month period refers to 
the surveillance period, not the length of time from the issuance of the 
order.

[72 FR 17400, Apr. 9, 2007]