[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: 21CFR822.38]

[Page 173]
 
                        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 G_Records and Reports
 
Sec. 822.38  What reports must I submit to you?

    You must submit interim and final reports as specified in your 
approved postmarket surveillance plan. In addition, we may ask you to 
submit additional information when we believe that the information is 
necessary for the protection of the public health and implementation of 
the act. We will also state the reason or purpose for the request and 
how we will use the information.