[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: 21CFR822.21]

[Page 170]
 
                        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. 822.21  What must I do if I want to make changes to my
postmarket surveillance plan after you have approved it?

    You must receive our approval in writing before making changes in 
your plan that will affect the nature or validity of the data collected 
in accordance with the plan. To obtain our approval, you must submit 
three copies of the request to make the proposed change and revised 
postmarket surveillance plan to the applicable address listed in Sec. 
822.8. You may reference information already submitted in accordance 
with Sec. 822.14. In your cover letter, you must identify your 
submission as a supplement and cite the unique document number that we 
assigned in our acknowledgment letter for your original submission, 
specifically identify the changes to the plan, and identify the reasons 
and justification for making the changes. You must report changes in 
your plan that will not affect the nature or validity of the data 
collected in accordance with the plan in the next interim report 
required by your approval order.