CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

Help | More About 21CFR

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR830.20]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

Subpart B - Requirements for a Unique Device Identifier

Sec. 830.20 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.

[78 FR 58825, Sept. 24, 2013]