Regulatory Text
21 C.F.R. § 830.20 — Requirements for a unique device identifier.
§ 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]
Source: ecfr.gov · govinfo.gov — public domain
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BS-CFR21-SEC-B0D9CD
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REGULATION / FEDERAL-CFR-SECTION
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boisestandard.org
Citation
21 C.F.R. § 830.20
Corpus
CFR — Code of Federal Regulations
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The regulatory text of 21 C.F.R. § 830.20 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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Title 21 — Food and Drugs
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21 C.F.R. — public domain
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