830.300 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.