§ 830.340 Voluntary submission of ancillary device identification information.

§ 830.340 Voluntary submission of ancillary device identification information.

(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 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 www.fda.gov/udi/ at least 60 days before making the change.