21 CFR § 830.210 - Eligibility for use of FDA as an issuing agency.

---
identifier: "/us/cfr/t21/s830.210"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 830.210 - Eligibility for use of FDA as an issuing agency."
title_number: 21
title_name: "Food and Drugs"
section_number: "830.210"
section_name: "Eligibility for use of FDA as an issuing agency."
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"
---


# 830.210 Eligibility for use of FDA as an issuing agency.

When FDA acts as an issuing agency, any labeler will be permitted to use FDA's unique device identification system, regardless of whether the labeler is considered a small business.