[Title 21 CFR F]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter H - MEDICAL DEVICES]
[Part 820 - QUALITY SYSTEM REGULATION]
[Subpart F - Identification and Traceability]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS81999-04-011999-04-01falseFSubpart FFOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICESQUALITY SYSTEM REGULATION
               Subpart F--Identification and Traceability



Sec. 820.60  Identification.

    Each manufacturer shall establish and maintain procedures for 
identifying product during all stages of receipt, production, 
distribution, and installation to prevent mixups.



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.