Devices subject to device identification data submission requirements.

§ 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.