[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: 21CFR822.22]

[Page 162]
 
                        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. 822.22  What recourse do I have if I do not agree with your decision?

    (a) If you disagree with us about the content of your plan or if we 
disapprove your plan, or if you believe there is a less burdensome 
approach that will answer the surveillance question, you may request 
review of our decision by:
    (1) Requesting a meeting with the Director, Office of Surveillance 
and Biometrics, Center for Devices and Radiological Health (CDRH), 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 CDRH Web site and from the CDRH Facts-on-Demand System (800-
899-0381 or 301-827-0111).