[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: 21CFR822.8]

[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 C--Postmarket Surveillance Plan
 
Sec. 822.8  When, where, and how must I submit my postmarket surveillance plan?


    You must submit your plan to conduct postmarket surveillance within 
30 days of the date you receive the postmarket surveillance order. For 
devices regulated by the Center for Devices and Radiological Health, you 
should send three copies of your submission to the Center for Devices 
and Radiological Health, Postmarket Surveillance Document Center (HFZ-
510), 1350 Piccard Dr., Rockville, MD, 20850. For devices regulated by 
the Center for Biologics Evaluation and Research, send three copies of 
your submission to the Center for Biologics Evaluation and Research, 
Document Control Center, 1401 Rockville Pike, suite 200N, Rockville, MD 
20852-1448. When we receive your original submission, we will send you 
an acknowledgment letter identifying the unique document number assigned 
to your submission. You must use this number in any correspondence 
related to this submission.