§830.300. Devices subject to device identification data submission requirements.
21 C.F.R. § 830.300
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).
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.
Exclusions. FDA may reject or remove any device identification data where:
The device identifier submitted does not conform to § 830.20;
The information concerns a device that is neither manufactured in the United States nor in interstate commerce in the United States,
The information concerns a product that FDA determines is not a device or a combination product that includes a device constituent part,
The information concerns a device or a combination product that requires, but does not have, FDA premarket approval, licensure, or clearance;
A device that FDA has banned under section 516 of the Federal Food, Drug, and Cosmetic Act; or
FDA has suspended the accreditation of the issuing agency that operates the system used by the labeler.
Notes, amendments, and revision history
Source
Source: 78 FR 58826, Sept. 24, 2013, unless otherwise noted.
Authority
Authority: 21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 371.
Source
Source: 78 FR 58823, Sept. 24, 2013, unless otherwise noted.