21 CFR 830.210
§ 830.210 Eligibility for use of FDA as an issuing agency.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 830.210, § 830.210 Eligibility for use of FDA as an issuing agency, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88980
- Permanent ID
ys:prov:88980@1- SHA-256
92812f04456d6aa7c0d69a8ae4334490a0641f18e28e303c07096c491bac7a69
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.