[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: 21CFR822.16]

[Page 161]
 
                        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. 822.16  What will you consider in the review of my submission?


    First, we will determine that the submission is administratively 
complete. Then, in accordance with the law, we must determine whether 
the designated person has appropriate qualifications and experience to 
conduct the surveillance and whether the surveillance plan will result 
in the collection of useful data that will answer the surveillance 
question.