[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: 21CFR822.8]

[Page 168]
 
                        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 Biologics Evaluation and Research, 
send three copies of your submission to the Document Control Center 
(HFM-99), Center for Biologics Evaluation and Research, Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. For devices regulated by the Center for Drug Evaluation and 
Research, send three copies of your submission to the Central Document 
Room, Center for Drug Evaluation and Research, Food and Drug 
Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266. 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.

[67 FR 38887, June 6, 2002, as amended at 70 FR 14986, Mar. 24, 2005]