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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 Dec 22, 2023.

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

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[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR830.10]
 See Related Information on Incorporation by reference. 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. 830.10 Incorporation by reference.

(a) Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, the Food and Drug Administration must publish notice of change in the Federal Register and the material must be available to the public. All approved material is available for inspection at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 301-827-6860, and is available from the source listed in paragraph (b) of this section. Copies are also available for purchase from the American National Standards Institute (ANSI), mailing address: ANSI, Attn: Customer Service Department, 25 West 43rd St., 4th floor, New York, NY 10036, phone: 212-642-4980, and may be ordered online at http://webstore.ansi.org/. The material is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(b) International Organization for Standardization (ISO), mailing address: ISO, Attn: ISO Central Secretariat, 1, ch. de la Voie-Creuse, Case postale 56, CH-1211 Geneva 20, Switzerland, phone (dialing from the United States): 011-41-22-749-0111, and may be ordered online at http://www.standardsinfo.net.

(1) ISO/IEC 646:1991(E), Information technology - ISO 7-bit coded character set for information interchange (third edition; December 15, 1991), into §§ 830.20(c) and 830.100(b);

(2) ISO/IEC 15459-2:2006(E), Information technology - Unique identifiers - Part 2: Registration procedures (second edition; March 1, 2006), into §§ 830.20(b) and 830.100(b);

(3) ISO/IEC 15459-4:2008(E), Information technology - Unique identifiers - Part 4: Individual items (second edition; July 15, 2008), into §§ 830.20(b) and 830.100(b);

(4) ISO/IEC 15459-6:2007(E), Information technology - Unique identifiers - Part 6: Unique identifier for product groupings (first edition; June 15, 2007), into §§ 830.20(b) and 830.100(b).

[78 FR 58823, Sept. 24, 2013, as amended at 88 FR 45067, July 14, 2023]

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