Title 21: Food and Drugs
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/ PART 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
/ Subpart C - Requirements for Manufacturers and Producers / § 809.20 General requirements for manufacturers and producers of in vitro diagnostic products.
§ 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 § 610.44 of this chapter.