[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: 21CFR803.30]

[Page 54]
 
                        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 C_User Facility Reporting Requirements
 
Sec.  803.30  If I am a user facility, what reporting requirements apply to 


me?

    (a) You must submit reports to the manufacturer or to us, or both, 
as specified below:
    (1) Reports of death. You must submit a report to us as soon as 
practicable but no more than 10 work days after the day that you become 
aware of information, from any source, that reasonably suggests that a 
device has or may have caused or contributed to the death of a patient 
of your facility. You must also submit the report to the device 
manufacturer, if known. You must report information required by Sec.  
803.32 on FDA Form 3500A or an electronic equivalent approved under 
Sec.  803.14.
    (2) Reports of serious injury. You must submit a report to the 
manufacturer of the device no later than 10 work days after the day that 
you become aware of information, from any source, that reasonably 
suggests that a device has or may have caused or contributed to a 
serious injury to a patient of your facility. If the manufacturer is not 
known, you must submit the report to us. You must report information 
required by Sec.  803.32 on FDA Form 3500A or an electronic equivalent 
approved under Sec.  803.14.
    (b) What information does FDA consider ``reasonably known'' to me? 
You must submit all information required in this subpart C that is 
reasonably known to you. This information includes information found in 
documents that you possess and any information that becomes available as 
a result of reasonable followup within your facility. You are not 
required to evaluate or investigate the event by obtaining or evaluating 
information that you do not reasonably know.