[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.184]

[Page 149]
 
                        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 M--Records
 
Sec. 820.184  Device history record.

    Each manufacturer shall maintain device history records (DHR's). 
Each manufacturer shall establish and maintain procedures to ensure that 
DHR's for each batch, lot, or unit are maintained to demonstrate that 
the device is manufactured in accordance with the DMR and the 
requirements of this part. The DHR shall include, or refer to the 
location of, the following information:
    (a) The dates of manufacture;
    (b) The quantity manufactured;
    (c) The quantity released for distribution;
    (d) The acceptance records which demonstrate the device is 
manufactured in accordance with the DMR;
    (e) The primary identification label and labeling used for each 
production unit; and
    (f) Any device identification(s) and control number(s) used.