[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: 21CFR822.10]

[Page 160]
 
                        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 C--Postmarket Surveillance Plan
 
Sec. 822.10  What must I include in my surveillance plan?

    Your surveillance plan must include a discussion of:
    (a) The plan objective(s) addressing the surveillance question(s) 
identified in our order;
    (b) The subject of the study, e.g., patients, the device, animals;
    (c) The variables and endpoints that will be used to answer the 
surveillance question, e.g., clinical parameters or outcomes;
    (d) The surveillance approach or methodology to be used;
    (e) Sample size and units of observation;
    (f) The investigator agreement, if applicable;
    (g) Sources of data, e.g., hospital records;
    (h) The data collection plan and forms;
    (i) The consent document, if applicable;
    (j) Institutional Review Board information, if applicable;
    (k) The patient followup plan, if applicable;
    (l) The procedures for monitoring conduct and progress of the 
surveillance;
    (m) An estimate of the duration of surveillance;
    (n) All data analyses and statistical tests planned;
    (o) The content and timing of reports.