21 CFR 830.340
§ 830.340 Voluntary submission of ancillary device identification information.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 830.340, § 830.340 Voluntary submission of ancillary device identification information, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88987
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Full text
(a) You may not submit any information to the Global Unique Device Identification Database (GUDID) other than that specified by § 830.310, except where FDA acts to permit the submission of specified additional types of information, termed ancillary information.
(b) FDA will provide information through the FDA Web site at http://www.fda.gov/udi/ concerning the types of ancillary information that may be submitted to the GUDID.
(c) FDA may periodically change the types of ancillary information that may be submitted to the GUDID. We will announce any change on the FDA Web site at http://www.fda.gov/udi/ at least 60 days before making the change.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.