[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
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 
and, if applicable, with Sec. 610.44 of this chapter.

[41 FR 6903, Feb. 13, 1976, as amended at 42 FR 42530, Aug. 23, 1977; 43 
FR 31527, July 21, 1978; 66 FR 31165, June 11, 2001]