part_subject: "IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE"
subpart_code: "C"
subpart_subject: "Requirements for Manufacturers and Producers"
section_number: "809.20"
section_subject: "General requirements for manufacturers and producers of in vitro diagnostic products."
cfr_reference: "21 CFR 809.20"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
(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.