We describe and respond to the comments in section II of this document. We have grouped comments into several broad topics that reflect the primary concerns of similar comments, and have identified the section or sections of the final rule (or the proposed rule, when appropriate) that are most closely related to each topic. The order in which each topic or comment is discussed is purely for organizational purposes and does not signify a comment's value or importance.
II. Comments on the Proposed Rule and
A. Definitions--21 CFR 801.3, 803.3, 806.2, 810.2, 814.3, 820.3, 821.3, 822.3, and 830.3
FDA received many comments (approximately 42) suggesting changes to, or clarification concerning, the definitions proposed for inclusion in the rule.
Convenience kit --A comment suggested we should restrict the scope of this definition by including additional language: "A group of reusable devices bearing and identified by an ordering number, appearing only on shipping container(s) and/or invoices, does not constitute a convenience kit."
FDA does not agree that this additional language would clarify the definition; rather, we believe this addition would be more likely to confuse labelers than help them understand how the rule applies to convenience kits. A convenience kit, or any other device subject to this rule, may be identified by a wide variety of numbers or other identifiers for a wide variety of purposes. The use of catalog numbers, inventory numbers, ordering numbers, or any other identification number is neither prohibited nor regulated by this rule, except that
FDA does not agree that convenience kits should be excluded from the final rule. Convenience kits are in wide use and are medical devices in their own right, apart from their constituent devices; their exclusion would leave a significant gap in the coverage of the rule and would undermine the effectiveness of the UDI system because they are controlled in the supply chain by the kit rather than by constituent part.
The final rule adopts the definition of convenience kit provided by the proposed rule, without change. The final rule does, however, include important changes that we believe address the underlying concerns of these comments. Section 801.30(a)(11) now provides that the label of devices packaged within the immediate container of a convenience kit do not have to bear a UDI as long as the label of the convenience kit bears a UDI. This change will make clear that labelers do not have to change the way they label convenience kits, including in vitro diagnostic kits, except for including a UDI on the kit label.
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