21 CFR §830.340
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
- (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.