[Title 21 CFR 820.160]
[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 L - Handling, Storage, Distribution, and Installation]
[Sec. 820.160 - Distribution.]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS81999-04-011999-04-01false820.160Sec. 820.160FOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICESQUALITY SYSTEM REGULATIONHandling, Storage, Distribution, and Installation
Sec. 820.160  Distribution.

    (a) Each manufacturer shall establish and maintain procedures for 
control and distribution of finished devices to ensure that only those 
devices approved for release are distributed and that purchase orders 
are reviewed to ensure that ambiguities and errors are resolved before 
devices are released for distribution. Where a device's fitness for use 
or quality deteriorates over time, the procedures shall ensure that 
expired devices or devices deteriorated beyond acceptable fitness for 
use are not distributed.
    (b) Each manufacturer shall maintain distribution records which 
include or refer to the location of:
    (1) The name and address of the initial consignee;
    (2) The identification and quantity of devices shipped;
    (3) The date shipped; and
    (4) Any control number(s) used.