21 CFR § 809.20 - General requirements for manufacturers and producers of in vitro diagnostic products.

---
identifier: "/us/cfr/t21/s809.20"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 809.20 - General requirements for manufacturers and producers of in vitro diagnostic products."
title_number: 21
title_name: "Food and Drugs"
section_number: "809.20"
section_name: "General requirements for manufacturers and producers of in vitro diagnostic products."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "809"
part_name: "IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321(h)(1), 331, 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 371, 372, 374, 381, and 42 U.S.C. 262."
cfr_part: "809"
---


# 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.

[41 FR 6903, Feb. 13, 1976, as amended at 42 FR 42530, Aug. 23, 1977; 43 FR 31527, July 21, 1978; 66 FR 31165, June 11, 2001]