[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: 21CFR809.20]

[Page 89]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 809--IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE--Table of Contents
 
         Subpart C--Requirements for Manufacturers and Producers
 
Sec. 809.20  General requirements for manufacturers and producers of in vitro diagnostic products.


    (a) [Reserved]
    (b) Compliance with good manufacturing practices. In vitro 
diagnostic products shall be manufactured in accordance with the good 
manufacturing practices requirements found in part 820 of this chapter.

[41 FR 6903, Feb. 13, 1976, as amended at 42 FR 42530, Aug. 23, 1977; 43 
FR 31527, July 21, 1978]