N. General Exceptions From the Requirement for the Label of a Device To Bear a Unique Device Identifier--Exception for a Device Held by the Strategic National Stockpile and Granted an Exception or Alternative Under SEC 801.128(f)(2)-
FDA received two comments that opposed this exception, which would provide the Strategic National Stockpile (SNS) the same latitude with regard to UDI labeling as is provided for other labeling requirements. The commenters believe that proper SNS management requires expiration dates on devices and the removal of recalled devices.
FDA declines to remove this exception, which runs parallel with other exceptions or alternatives granted under
O. General Exceptions From the Requirement for the Label of a Device To Bear a Unique Device Identifier. The Unique Device Identifier of a Class I Device Is Not Required to Include a Production Identifier--
FDA received approximately seven comments on this exception. Three comments supported the exception or recommended expansion of the exception. For example, a comment suggested
FDA does not agree that this exception should be modified. We agree that production identifiers are important, but we have provided this limited exception to avoid imposing significant burdens on lower risk devices, where the public health need for precise identification is less urgent than for moderate- and high-risk devices. The final rule adopts the proposed exception without any change.
P. Requests for Additional General Exceptions From the Requirement for the Label of a Device To Bear a Unique Device Identifier
Several comments suggested that the final rule should provide additional exceptions to
* A comment recommended "HCT/Ps . . . be exempted from the UDI Final Rule."
* A comment suggested that analyte-specific reagents that can, by regulation, be sold only to certain entities and which "are not directly used in any health care setting" should be exempted from UDI requirements.
* A comment suggested that an orthopedic procedure tray should not be treated as a medical device, but as a type of shipping container, as the contents vary with every shipment "due to patient needs."
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