21 CFR § 801.119 - In vitro diagnostic products.

---
identifier: "/us/cfr/t21/s801.119"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 801.119 - In vitro diagnostic products."
title_number: 21
title_name: "Food and Drugs"
section_number: "801.119"
section_name: "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: "801"
part_name: "LABELING"
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, 331-334, 351, 352, 360d, 360i, 360j, 371, 374."
regulatory_source: "41 FR 6896, Feb. 13, 1976, unless otherwise noted."
cfr_part: "801"
---


# 801.119 In vitro diagnostic products.

A product intended for use in the diagnosis of disease and which is an in vitro diagnostic product as defined in § 809.3(a) of this chapter shall be deemed to be in compliance with the requirements of this part and section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act if it meets the requirements of subpart B of this part and the requirements of § 809.10 of this chapter.

[78 FR 58820, Sept. 24, 2013]