The final rule makes no changes to the language of proposed
T. Form of a Unique Device Identifier--Unique Device Identifier To Include Device Identifier and Production Identifier--Proposed
FDA received a few comments (approximately four) on these requirements.
Three comments suggested that if HCT/Ps regulated as devices are subject to the rule, the distinct identification code required in
FDA agrees with this view, and we have added "the distinct identification code required by
One comment raised a concern about how production identifiers would apply to laboratory-developed tests (LDTs). Another comment claimed that LDTs are services, do not fall within the definition of "device" at section 201(h) of the FD&C Act, and that
As this rule does not make changes to what qualifies as a "device" under section 201(h) of the FD&C Act, this comment is beyond the scope of this final rule.
U. Form of a Unique Device Identifier--Proposed Symbol To Indicate the Presence of Automatic Identification and Capture Technology--Proposed
Proposed SEC 801.45(c) would have required a device label or device package to bear a symbol indicating the presence of AIDC technology whenever the AIDC "is not evident upon visual examination of the label or device package." The proposed language identified the types of symbols that could be used. Among the types of symbols permitted was an
We received many comments (approximately 40) on this proposal. None of these comments expressed support for the
In response to these comments,
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