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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

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

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2019]
[CITE: 21CFR830.20]
See Related Information on Requirements for a unique device identifier. in CDRH databases



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

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 55825, Sept. 24, 2013]

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