[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR822.32]

[Page 178]
 
                        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. 822.32  What records are the investigators in my surveillance 
plan required to keep?

    Your investigator must keep copies of:
    (a) All correspondence between investigators, FDA, the manufacturer, 
and the designated person, including required reports.
    (b) The approved postmarket surveillance plan, with documentation of 
the date and reason for any deviation from the plan.
    (c) All data collected and analyses conducted at that site for 
postmarket surveillance.
    (d) Any other records that we require to be maintained by regulation 
or by order.