[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.170]

[Page 162]
 
                        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 L_Handling, Storage, Distribution, and Installation
 
Sec. 820.170  Installation.

    (a) Each manufacturer of a device requiring installation shall 
establish and maintain adequate installation and inspection 
instructions, and where appropriate test procedures. Instructions and 
procedures shall include directions for ensuring proper installation so 
that the device will perform as intended after installation. The 
manufacturer shall distribute the instructions and procedures with the 
device or otherwise make them available to the person(s) installing the 
device.
    (b) The person installing the device shall ensure that the 
installation, inspection, and any required testing are performed in 
accordance with the manufacturer's instructions and procedures and shall 
document the inspection and any test results to demonstrate proper 
installation.

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