Section 830.300 - Devices subject to device identification data submission requirements(a)In general. The labeler of a device must provide the information required by this subpart for each version or model required to bear a unique device identifier (UDI).(b)Voluntary submission of information. If a labeler voluntarily includes a UDI on the label of a device under § 801.40 , the labeler may also voluntarily submit information concerning that device under this part.(c)Exclusions. FDA may reject or remove any device identification data where:(1) The device identifier submitted does not conform to § 830.20 ;(2) The information concerns a device that is neither manufactured in the United States nor in interstate commerce in the United States,(3) The information concerns a product that FDA determines is not a device or a combination product that includes a device constituent part,(4) The information concerns a device or a combination product that requires, but does not have, FDA premarket approval, licensure, or clearance;(5) A device that FDA has banned under section 516 of the Federal Food, Drug, and Cosmetic Act; or(6) FDA has suspended the accreditation of the issuing agency that operates the system used by the labeler.