eCFR Reference Browser

---

title: "21 CFR §807.39"

source: "https://www.ecfr.gov/current/title-21/section-807.39"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "807"

part_subject: "ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES"

subpart_code: "B"

subpart_subject: "Procedures for Device Establishments"

section_number: "807.39"

section_subject: "Misbranding by reference to establishment registration or to registration number."

cfr_reference: "21 CFR 807.39"

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"

---

Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.

§807.39 - Misbranding by reference to establishment registration or to registration number.