21 CFR §830.300

1. (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).
2. (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.
3. (c)Exclusions. FDA may reject or remove any device identification data where:
   1. (1)The device identifier submitted does not conform to § 830.20;
   2. (2)The information concerns a device that is neither manufactured in the United States nor in interstate commerce in the United States,
   3. (3)The information concerns a product that FDA determines is not a device or a combination product that includes a device constituent part,
   4. (4)The information concerns a device or a combination product that requires, but does not have, FDA premarket approval, licensure, or clearance;
   5. (5)A device that FDA has banned under section 516 of the Federal Food, Drug, and Cosmetic Act; or
   6. (6)FDA has suspended the accreditation of the issuing agency that operates the system used by the labeler.