[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.30]

[Page 48-49]
 
                        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  Individual adverse event reports; user facilities.


    (a) Reporting standard. A user facility shall submit the following 
reports to the manufacturer or to FDA, or both, as specified below:
    (1) Reports of death. Whenever a user facility receives or otherwise 
becomes 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 the facility, the facility shall as soon as practicable, but 
not later than 10 work days after becoming aware of the information, 
report the information required by Sec. 803.32 to FDA, on FDA Form 
3500A, or an electronic equivalent as approved under Sec. 803.14, and if 
the identity of the

[[Page 49]]

manufacturer is known, to the device manufacturer.
    (2) Reports of serious injury. Whenever a user facility receives or 
otherwise becomes 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 the facility, the facility shall, as soon 
as practicable but not later than 10 work days after becoming aware of 
the information, report the information required by Sec. 803.32, on FDA 
Form 3500A or electronic equivalent, as approved under Sec. 803.14, to 
the manufacturer of the device. If the identity of the manufacturer is 
not known, the report shall be submitted to FDA.
    (b) Information that is reasonably known to user facilities. User 
facilities must provide all information required in this subpart C that 
is reasonably known to them. Such information includes information found 
in documents in the possession of the user facility and any information 
that becomes available as a result of reasonable followup within the 
facility. A user facility is not required to evaluate or investigate the 
event by obtaining or evaluating information that is not reasonably 
known to it.