(a) The labeler shall submit to FDA the information required by Sec. 830.310 no later than the date the label of the device must bear a unique device identifier under Sec. 801.20 of this chapter.
(b) The labeler of a device shall submit to FDA an update to the information required by Sec. 830.310 whenever the information changes. The updated information must be submitted no later than the date a device is first labeled with the changed information. If the information does not appear on the label of a device, the updated information must be submitted within 10 business days of the change.