[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: 21CFR803.1]

[Page 39]
 
                        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  Scope.


    (a) This part establishes requirements for medical device reporting. 
Under this part, device user facilities, importers, and manufacturers, 
as defined in Sec. 803.3, must report deaths and serious injuries to 
which a device has or may have caused or contributed, must establish and 
maintain adverse event files, and must submit to FDA specified followup 
and summary reports. Medical device distributors, as defined in 
Sec. 803.3, are also required to maintain records of incidents (files). 
Furthermore, manufacturers and importers are also required to report 
certain device malfunctions. These reports will assist FDA in protecting 
the public health by helping to ensure that devices are not adulterated 
or misbranded and are safe and effective for their intended use.
    (b) This part supplements and does not supersede other provisions of 
this subchapter, 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.

[60 FR 63597, Dec. 11, 1995, as amended at 62 FR 13306, Mar. 20, 1997; 
65 FR 4118, Jan. 26, 2000]