eCFR Reference Browser

---

title: "21 CFR §830.50"

source: "https://www.ecfr.gov/current/title-21/section-830.50"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "830"

part_subject: "UNIQUE DEVICE IDENTIFICATION"

subpart_code: "B"

subpart_subject: "Requirements for a Unique Device Identifier"

section_number: "830.50"

section_subject: "Changes that require use of a new device identifier."

cfr_reference: "21 CFR 830.50"

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)Whenever you make a change to a device that is required to bear a unique device identifier (UDI) on its label, and the change results in a new version or model, you must assign a new device identifier to the new version or model.

(b)Whenever you create a new device package, you must assign a new device identifier to the new device package.

§830.50 - Changes that require use of a new device identifier.