[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: 21CFR820.5]

[Page 141]
 
                        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 A--General Provisions
 
Sec. 820.5  Quality system.

    Each manufacturer shall establish and maintain a quality system that 
is appropriate for the specific medical device(s) designed or 
manufactured, and that meets the requirements of this part.