eCFR Reference Browser

---

title: "21 CFR §801.35"

source: "https://www.ecfr.gov/current/title-21/section-801.35"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "801"

part_subject: "LABELING"

subpart_code: "B"

subpart_subject: "Labeling Requirements for Unique Device Identification"

section_number: "801.35"

section_subject: "Voluntary labeling of a device with a unique device identifier."

cfr_reference: "21 CFR 801.35"

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)The labeler of a device that is not required to bear a unique device identifier (UDI) may voluntarily comply with § 801.20. If a labeler voluntarily includes a UDI for a device, the labeler may voluntarily provide information concerning the device under subpart E of part 830 of this chapter.

(b)A device may bear both a Universal Product Code (UPC) and a UDI on its label and packages.

§801.35 - Voluntary labeling of a device with a unique device identifier.