CFR section
21 CFR 809.20(b): General requirements for manufacturers and producers of in vitro diagnostic products
PART 809-IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE · Subpart C-Requirements for Manufacturers and Producers
Key facts
| Citation | 21 CFR 809.20(b) |
|---|---|
| Section | General requirements for manufacturers and producers of in vitro diagnostic products |
| Part | PART 809-IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE |
| Subpart | Subpart C-Requirements for Manufacturers and Producers |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (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. |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.