21 CFR § 830.10 - Incorporation by reference.

---
identifier: "/us/cfr/t21/s830.10"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 830.10 - Incorporation by reference."
title_number: 21
title_name: "Food and Drugs"
section_number: "830.10"
section_name: "Incorporation by reference."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "830"
part_name: "UNIQUE DEVICE IDENTIFICATION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 371."
regulatory_source: "78 FR 58823, Sept. 24, 2013, unless otherwise noted."
cfr_part: "830"
---


# 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]