§ 830.300. Devices subject to device identification data submission requirements.
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/us/cfr/t21/s§ 830.300·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.
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§ 830.300
Devices subject to device identification data submission requirements.
Fed. Reg.×5
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