[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.16]

[Page 50]
 
                        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  When I submit a report, does the information in my report 

constitute an admission that the device caused or contributed to the 

reportable event?

    No. A report or other information submitted by you, and our release 
of that report or information, is not necessarily an admission that the 
device, or you or your employees, caused or contributed to the 
reportable event. You do not have to admit and may deny that the report 
or information submitted under this part constitutes an admission that 
the device, you, or your employees, caused or contributed to a 
reportable event.