[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: 21CFR803.16]

[Page 45]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 803--MEDICAL DEVICE REPORTING--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 803.16  Disclaimers.

    A report or other information submitted by a reporting entity under 
this part, and any release by FDA of that report or information, does 
not necessarily reflect a conclusion by the party submitting the report 
or by FDA that the report or information constitutes an admission that 
the device, or the reporting entity or its employees, caused or 
contributed to the reportable event. The reporting entity need not admit 
and may deny that the report or information submitted under this part 
constitutes an admission that the device, the party submitting the 
report, or employees thereof, caused or contributed to a reportable 
event.