[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: 21CFR822.7]

[Page 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 B--Notification
 
Sec. 822.7  What should I do if I do not agree that postmarket surveillance is appropriate?

    (a) If you do not agree with our decision to order postmarket 
surveillance for a particular device, you may request review of our 
decision by:
    (1) Requesting a meeting with the Director, Office of Surveillance 
and Biometrics, who generally issues the order for postmarket 
surveillance;
    (2) Seeking internal review of the order under Sec. 10.75 of this 
chapter;
    (3) Requesting an informal hearing under part 16 of this chapter; or
    (4) Requesting review by the Medical Devices Dispute Resolution 
Panel of the Medical Devices Advisory Committee.
    (b) You may obtain guidance documents that discuss these mechanisms 
from the Center for Devices and Radiological Health's (CDRH's) Web site 
(www.fda.gov/cdrh/resolvingdisputes), and from the CDRH Facts-on-Demand 
system (800-899-0381 or 301-827-0111).