[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.46]

[Page 110]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS--Table of Contents
 
                 Subpart C--Responsibilities of Sponsors
 
Sec. 812.46  Monitoring investigations.

    (a) Securing compliance. A sponsor who discovers that an 
investigator is not complying with the signed agreement, the 
investigational plan, the requirements of this part or other applicable 
FDA regulations, or any conditions of approval imposed by the reviewing 
IRB or FDA shall promptly either secure compliance, or discontinue 
shipments of the device to the investigator and terminate the 
investigator's participation in the investigation. A sponsor shall also 
require such an investigator to dispose of or return the device, unless 
this action would jeopardize the rights, safety, or welfare of a 
subject.
    (b) Unanticipated adverse device effects. (1) A sponsor shall 
immediately conduct an evaluation of any unanticipated adverse device 
effect.
    (2) A sponsor who determines that an unanticipated adverse device 
effect presents an unreasonable risk to subjects shall terminate all 
investigations or parts of investigations presenting that risk as soon 
as possible. Termination shall occur not later than 5 working days after 
the sponsor makes this determination and not later than 15 working days 
after the sponsor first received notice of the effect.
    (c) Resumption of terminated studies. If the device is a significant 
risk device, a sponsor may not resume a terminated investigation without 
IRB and FDA approval. If the device is not a significant risk device, a 
sponsor may not resume a terminated investigation without IRB approval 
and, if the investigation was terminated under paragraph (b)(2) of this 
section, FDA approval.