GroundRules
21 CFR 809.20: General requirements for manufacturers and producers of in vitro diagnostic products.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
- Subpart C—Requirements for Manufacturers and Producers
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON