21 CFR § 830.300 - Devices subject to device identification data submission requirements.
---
identifier: "/us/cfr/t21/s830.300"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 830.300 - Devices subject to device identification data submission requirements."
title_number: 21
title_name: "Food and Drugs"
section_number: "830.300"
section_name: "Devices subject to device identification data submission requirements."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "830"
part_name: "UNIQUE DEVICE IDENTIFICATION"
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, 352, 353, 360, 360d, 360i, 360j, 371."
regulatory_source: "78 FR 58823, Sept. 24, 2013, unless otherwise noted."
cfr_part: "830"
---
# 830.300 Devices subject to device identification data submission requirements.
(a) *In general.* The labeler of a device must provide the information required by this subpart for each version or model required to bear a unique device identifier (UDI).
(b) *Voluntary submission of information.* If a labeler voluntarily includes a UDI on the label of a device under § 801.40, the labeler may also voluntarily submit information concerning that device under this part.
(c) *Exclusions.* FDA may reject or remove any device identification data where:
(1) The device identifier submitted does not conform to § 830.20;
(2) The information concerns a device that is neither manufactured in the United States nor in interstate commerce in the United States,
(3) The information concerns a product that FDA determines is not a device or a combination product that includes a device constituent part,
(4) The information concerns a device or a combination product that requires, but does not have, FDA premarket approval, licensure, or clearance;
(5) A device that FDA has banned under section 516 of the Federal Food, Drug, and Cosmetic Act; or
(6) FDA has suspended the accreditation of the issuing agency that operates the system used by the labeler.