Code of Federal Regulations · Section
§ 809.20 — General Requirements For Manufacturers And Producers Of In Vitro Diagnostic Products
21 C.F.R. § 809.20
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(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.
Authorizing Statute
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Regulation of biological products42 U.S.C. § 262
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Definitions; generally21 U.S.C. § 321