eCFR Reference Browser

---

title: "21 CFR §801.119"

source: "https://www.ecfr.gov/current/title-21/section-801.119"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "801"

part_subject: "LABELING"

subpart_code: "D"

subpart_subject: "Exemptions From Adequate Directions for Use"

section_number: "801.119"

section_subject: "In vitro diagnostic products."

cfr_reference: "21 CFR 801.119"

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"

---

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.

§801.119 - In vitro diagnostic products.