{"data":{"id":"us/21-cfr-830.20","jurisdiction":"us","citation":"21 CFR 830.20","heading":"Requirements for a unique device identifier.","body":"A unique device identifier (UDI) must:\n(a) Be issued under a system operated by FDA or an FDA-accredited issuing agency;\n(b) Conform to each of the following international standards:\n(1) ISO/IEC 15459-2, which is incorporated by reference at § 830.10;\n(2) ISO/IEC 15459-4, which is incorporated by reference at § 830.10; and\n(3) ISO/IEC 15459-6, which is incorporated by reference at § 830.10.\n(c) Use only characters and numbers from the invariant character set of ISO/IEC 646, which is incorporated by reference at § 830.10.","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 B—Requirements for a Unique Device Identifier"],"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":"ebd47d1bad7566a2e055213fb0373caa6c59e427eca02d4d1a7a4431f502c0b6","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-830.10","next":"us/21-cfr-830.40"},"notice":"GroundRules: Original legal text. Not legal advice."}