[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

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  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.