[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: 21CFR822.30]

[Page 172]
 
                        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 F_Waivers and Exemptions
 
Sec. 822.30  May I request exemption from the requirement to conduct
postmarket surveillance?

    You may request exemption from the requirement to conduct postmarket 
surveillance for your device or any specific model of that device at any 
time. You must comply with the requirements of this part unless and 
until we grant an exemption for your device. Your request for exemption 
must explain why you believe we should exempt the device or model from 
postmarket surveillance. You should demonstrate why the surveillance 
question does not apply to your device or does not need to be answered 
for the device for which you are requesting exemption. Alternatively, 
you may provide information that answers the surveillance question for 
your device, with supporting documentation, to the address in Sec. 
822.8.