[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: 21CFR822.31]

[Page 172]
 
                        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. 822.31  What records am I required to keep?


    You must keep copies of:
    (a) All correspondence with your investigators or FDA, including 
required reports;
    (b) Signed agreements from each of your investigators, if your 
surveillance plan uses investigators, stating the commitment to conduct 
the surveillance in accordance with the approved plan, any applicable 
FDA regulations, and any conditions of approval for your plan, such as 
reporting requirements;
    (c) Your approved postmarket surveillance plan, with documentation 
of the date and reason for any deviation from the plan;
    (d) All data collected and analyses conducted in support of your 
postmarket surveillance plan; and
    (e) Any other records that we require to be maintained by regulation 
or by order, such as copies of signed consent documents, evidence of 
Institutional Review Board review and approval, etc.