[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR821.60]

[Page 165]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 821_MEDICAL DEVICE TRACKING REQUIREMENTS--Table of Contents
 
                    Subpart D_Records and Inspections
 
Sec. 821.60  Retention of records.

    Persons required to maintain records under this part shall maintain 
such records for the useful life of each tracked device they manufacture 
or distribute. The useful life of a device is the time a device is in 
use or in distribution for use. For example, a record may be retired if 
the person maintaining the record becomes aware of the fact that the 
device is no longer in use, has been explanted, returned to the 
manufacturer, or the patient has died.