[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: 21CFR803.30]



[Page 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  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.