GroundRules
21 CFR 830.20: Requirements for a unique device identifier.
Where this section sits in the code
- 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
A unique device identifier (UDI) must:
(a) Be issued under a system operated by FDA or an FDA-accredited issuing agency;
(b) Conform to each of the following international standards:
(1) ISO/IEC 15459-2, which is incorporated by reference at § 830.10;
(2) ISO/IEC 15459-4, which is incorporated by reference at § 830.10; and
(3) ISO/IEC 15459-6, which is incorporated by reference at § 830.10.
(c) Use only characters and numbers from the invariant character set of ISO/IEC 646, which is incorporated by reference at § 830.10.
Collected 2026-08-27T02:24:47Z. Source file · JSON