[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: 21CFR822.25]

[Page 162]
 
                        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 E--Responsibilities of Manufacturers
 
Sec. 822.25  What are my responsibilities after my postmarket surveillance plan has been approved?

    After we have approved your plan, you must conduct the postmarket 
surveillance of your device in accordance with your approved plan. This 
means that you must ensure that:
    (a) Postmarket surveillance is initiated in a timely manner;
    (b) The surveillance is conducted with due diligence;
    (c) The data identified in the plan is collected;
    (d) Any reports required as part of your approved plan are submitted 
to us in a timely manner; and
    (e) Any information that we request prior to your submission of a 
report or in response to our review of a report is provided in a timely 
manner.

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