[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR809.20]



[Page 90]

 

                        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]