Device package --We received several comments concerning this definition and the application of the rule to device packages other than the "immediate container" of the device. For example, one comment suggested the definition is "too broad and requires clarification to ensure that is does not apply to a group of devices that are shipped together only as logistics or shipping units such as orthopedic trays." Another comment suggested that a UDI should be required on "regulated packaging" and noted that manufacturers commonly change quantities at higher levels of packaging for storage, logistics, and transportation purposes. Another comment did not specifically object to providing a UDI on varying device packages, but did not see a need for different UDIs on device packages that contain different quantities.
FDA disagrees that the UDI rule should not apply to device packages other than the immediate container, and that different device packages should not be identified by different UDIs. UDIs on all device packages are essential for rapid and efficient identification of devices that are the subject of a recall, a key objective of the UDI rule. The use of separate UDIs for higher level packaging reflects prevailing industry practices (Refs. 3, 14, and 15). Similarly, different UDIs are useful for each different device package because a device recall might target a specific device package while excluding other device packages; in addition, the requirement for different UDIs on different device packages recognizes current industry practices, which generally use different identifiers for each level of packaging and for packages with different quantities of devices. Accordingly, we have not modified the definition of device package in response to comments. Because packages that contain a convenience kit, an in vitro diagnostic product, an HCT/P regulated as a device, or a combination product with a device constituent part all contain a particular version or model of a device, such packages also meet the definition of "device package" and are required to bear a UDI by
Six comments argued that a UDI should be required to appear only on the label of a device, and not on higher levels of packaging based on the premise that section 519(f) of the FD&C Act narrowly requires a UDI only on the device label.
FDA disagrees with this comment. As explained in the preamble to the amended proposed rule, the presence of a UDI on the higher-level packaging of a device will enable
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