FDA disagrees. This rule is not changing the meanings of repackager or reprocessor; those terms will have the same meanings as they now have within other regulatory contexts, such as registration and listing and premarket review, and thus would be considered labelers.
Lot or batch --A comment requested clarification regarding how this term should be applied to HCT/Ps, "where the donor identification is of singular importance." Other comments mirrored this concern, stating that devices "derived from human tissue cannot be labeled by lot or batch, unless the lot or batch identification is associated with a single donor, as [21 CFR] 1271.220(b) disallows the pooling of human cells or tissue from two or more donors during manufacturing."
FDA agrees that these are valid concerns, but we believe that the phrases "manufactured under essentially the same conditions" and "intended to have uniform characteristics and quality within specified limits" in the definition of lot or batch are flexible enough to include the distinct identification code required by
Shipping container --We did not receive any comments suggesting changes to this definition, but we have included minor edits in the definition provided in the final rule. Deletion of the words "package" and "pallet," is meant to help to simplify the definition and avoid any confusion involving the defined term device package. These edits are not intended to change the meaning of the term.
Specification --A comment suggested that it would be better to define this term to mean a requirement with which a device must conform as documented in the Device Master Record consistent with
FDA disagrees. The definition we proposed is built on language drawn from the Quality Systems Regulation, is consistent with existing practice, and is clear. The final rule adopts the definition provided by the proposed rule, without change.
Unique device identifier (UDI) --A comment suggested, "If HCT/Ps regulated as medical devices are subject to the rule, we believe the donation identification number must also be considered a production identifier." The concern underlying this comment is similar to that of a comment cited previously, concerning lot or batch.
FDA agrees that this definition needs to be modified to address existing practices concerning the labeling and tracking of HCT/Ps regulated as devices. Accordingly, the final rule adds language to the definition of production identifier, which is part of the definition of unique device identifier (UDI). At the end of paragraph (2), we have added the following additional production identifier: "(v) For an HCT/P regulated as a device, the distinct identification code required by
Unique device identifier (UDI)--Production identifier. Comments requested clarification concerning one type of production identifier, the "date a specific device was manufactured." For example, one comment stated that "it would be beneficial for
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