[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: 21CFR820.65]

[Page 144]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 820--QUALITY SYSTEM REGULATION--Table of Contents
 
               Subpart F--Identification and Traceability
 
Sec. 820.65  Traceability.

    Each manufacturer of a device that is intended for surgical implant 
into the body or to support or sustain life and whose failure to perform 
when properly used in accordance with instructions for use provided in 
the labeling can be reasonably expected to result in a significant 
injury to the user shall establish and maintain procedures for 
identifying with a control number each unit, lot, or batch of finished 
devices and where appropriate components. The procedures shall 
facilitate corrective action. Such identification shall be documented in 
the DHR.