{"data":{"id":"us/21-cfr-830.300","jurisdiction":"us","citation":"21 CFR 830.300","heading":"Devices subject to device identification data submission requirements.","body":"(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).\n(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.\n(c) Exclusions. FDA may reject or remove any device identification data where:\n(1) The device identifier submitted does not conform to § 830.20;\n(2) The information concerns a device that is neither manufactured in the United States nor in interstate commerce in the United States,\n(3) The information concerns a product that FDA determines is not a device or a combination product that includes a device constituent part,\n(4) The information concerns a device or a combination product that requires, but does not have, FDA premarket approval, licensure, or clearance;\n(5) A device that FDA has banned under section 516 of the Federal Food, Drug, and Cosmetic Act; or\n(6) FDA has suspended the accreditation of the issuing agency that operates the system used by the labeler.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 830—UNIQUE DEVICE IDENTIFICATION","Subpart E—Global Unique Device Identification Database"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"cf4e619041f3811f25c86967bd8c9711c90cde1f9bc2cc4eb9f71b41c4daf283","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-830.220","next":"us/21-cfr-830.310"},"notice":"GroundRules: Original legal text. Not legal advice."}