A comment suggested
FDA disagrees. Such shipments are already generally governed by
Q. Request for Modification of Unique Device Identifier Labeling Requirements for Devices That Have Small Labels
Some comments suggested the rule should provide an exception from UDI labeling requirements "where the label is too small" to accommodate both human readable and AIDC information, "provided that the UDI appears on the next higher level of packaging." A similar comment suggested that if a device with a small label is included in a convenience kit, a UDI should be required only on the label of the convenience kit.
FDA believes that some of the concerns underlying these requests have been resolved by the revisions made to
FDA does not agree that any additional exception should be provided in the final rule based only on the size of the device label. First, the comments we received did not provide sufficient information to allow
R. Voluntary Labeling of a Device With a Unique Device Identifier--Proposed
FDA received two comments on this provision.
One comment stated voluntary UDI labeling will cause confusion, as most exempt devices will already bear a UPC.
FDA does not agree with this comment. We do not believe that any confusion will result from such labeling, as the formats of a UPC and a UDI will differ. The final rule permits, but does not require, a device to bear both a UDI and a UPC.
The other comment stated that if there are no categorical UDI exceptions, there would be no reason to allow voluntary UDI labeling.
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