[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: 21CFR803.10]

[Page 43-44]
 
                        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. 803.10  General description of reports required from user facilities, importers, and manufacturers.

    (a) Device user facilities. User facilities must submit the 
following reports, which are described more fully in subpart C of this 
part.
    (1) User facilities must submit MDR reports of individual adverse 
events within 10 days after the user facility becomes aware of an MDR 
reportable event as described in Secs. 803.30 and 803.32.
    (i) User facilities must submit reports of device-related deaths to 
FDA and to the manufacturer, if known.
    (ii) User facilities must submit reports of device-related serious 
injuries to manufacturers, or to FDA, if the manufacturer is unknown.
    (2) User facilities must submit annual reports as described in 
Sec. 803.33.
    (b) Device importers. Importers must submit the following reports, 
which are described more fully in subpart D of this part.
    (1) Importers must submit MDR reports of individual adverse events 
within 30 days after the importer becomes aware of an MDR reportable 
event as described in Secs.  803.40 and 803.42.
    (i) Importers must submit reports of device-related deaths or 
serious injuries to FDA and to the manufacturer.

[[Page 44]]

    (ii) Importers must submit reports of malfunctions to the 
manufacturer.
    (2) [Reserved]
    (c) Device manufacturers. Manufacturers must submit the following 
reports as described more fully in subpart E of this part:
    (1) MDR reports of individual adverse events within 30 days after 
the manufacturer becomes aware of a reportable death, serious injury, or 
malfunction as described in Secs. 803.50 and 803.52.
    (2) MDR reports of individual adverse events within 5 days of:
    (i) Becoming aware that a reportable MDR event requires remedial 
action to prevent an unreasonable risk of substantial harm to the public 
health or,
    (ii) Becoming aware of an MDR reportable event for which FDA has 
made a written request, as described in Sec. 803.53.
    (3) Annual baseline reports as described in Sec. 803.55.
    (4) Supplemental reports if they obtain information that was not 
provided in an initial report as described in Sec. 803.56.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000; 66 
FR 23157, May 8, 2001]