[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: 21CFR803.1]

[Page 44]
 
                        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.  803.1  What does this part cover?


    (a) This part establishes the requirements for medical device 
reporting for device user facilities, manufacturers, importers, and 
distributors. If you are a device user facility, you must report deaths 
and serious injuries that a device has or may have caused or contributed 
to, establish and maintain adverse event files, and submit summary 
annual reports. If you are a manufacturer or importer, you must report 
deaths and serious injuries that your device has or may have caused or 
contributed to, you must report certain device malfunctions, and you 
must establish and maintain adverse event files. If you are a 
manufacturer, you must also submit specified followup and baseline 
reports. These reports help us to protect the public health by helping 
to ensure that devices are not adulterated or misbranded and are safe 
and effective for their intended use. If you are a medical device 
distributor, you must maintain records (files) of incidents, but you are 
not required to report these incidents.
    (b) This part supplements and does not supersede other provisions of 
this chapter, including the provisions of part 820 of this chapter.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.