Finished device --We did not receive any comments concerning this definition. This term is used in the definition of lot or batch, and is included to clarify the meaning of that term. This term is also useful when determining the "date of manufacture" that should be used as a production identifier; see the discussion of Unique device identifier (UDI) --Production identifier, in this document.
HCT/P regulated as a device --We have added this definition, and made other changes that are discussed later in this document, to explain how the final rule applies to HCT/Ps that are regulated as devices.
Implantable device --Comments suggested
Such a change would result in unwarranted inconsistency with longstanding regulatory practice. For example, the definitions of implant used in 21 CFR parts 812 (investigational device exemptions) and 860 (medical device classification procedures) use the same 30-day criterion. The final rule adopts the definition provided by the proposed rule, without change. We note further that because
Labeler --A comment suggested that the definition's use of language referring to "the intent that the device will be introduced into interstate commerce" is not appropriate. Another comment suggested that the final rule should make clear that a health care system assembling "convenience kits" for distribution within its own system should not be a "labeler" and that such distribution is not interstate commerce. A somewhat similar comment suggested that "Hospitals, health care systems, and other entities that repackage devices, assemble kits, or reprocess single-use devices for internal use only . . . should not be subject to UDI-related requirements. . . ."
We believe that all of these concerns can be resolved by modifying the definition to refer to "commercial distribution," a term that has been in use for many years and which is used extensively in
FDA agrees a relabeler is a labeler under this rule. We expected that our use of "modified" in paragraph (2) of the definition would have been understood to include "replaced."
Another comment suggested that the final rule "must more specifically describe when a repackager, device reprocessor, or other non-manufacturer would be . . . considered a 'labeler' for UDI purposes."
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