FDA agrees it is appropriate to extend the exception to all classes of devices, except implants, and the final rule does so.
One comment requested clarification concerning how this exception would apply to reprocessed single-use devices. With respect to a single-use device, the term "reprocessed" means that the device has been subjected to additional processing or manufacturing after use on a patient for the purpose of rendering the device fit for an additional use on a patient. See FD&C Act section 201( ll)(2) (21 U.S.C. 321( ll)(2).
FDA sees no reason why a reprocessed SUD that meets the other criteria for this exception should be excluded from the scope of the exception.
J. General Exceptions From the Requirement for the Label of a Device To Bear a Unique Device Identifier--Exception for a Custom Device Within the Meaning of
FDA received approximately four comments on this proposed exception. One comment opposed this exception. Three comments recommended this exception be extended to specific devices: Cranial remolding orthoses, prescription eyewear, and contact lenses.
These are types of devices and do not categorically qualify as custom devices within the meaning of
K. General Exceptions From the Requirement for the Label of a Device To Bear a Unique Device Identifier--Exception for a Device Intended for Export from
FDA received two comments on this proposed exception. One comment opposed the exception, viewing it as inconsistent with a "truly harmonized global device identification system." The other comment recommended that class I single-use devices intended for export should bear a UDI.
FDA does not agree with either comment. There is no assurance that a UDI that meets U.S. regulatory requirements would meet the requirements of the nation to which a device is exported, and it is possible that U.S. UDI requirements conflict with the requirements of the nation to which a device is exported. For these reasons,
L. General Exceptions From the Requirement for the Label of a Device To Bear a Unique Device Identifier--Exception for a Device Packaged Within the Immediate Container of a Combination Product or Convenience Kit--Similar Requirements Proposed at
Proposed SEC 801.25 was titled, "Unique device identifiers for combination products, device constituent parts of a combination product, and devices packaged in a convenience kit." Section 801.25 would have required the label of every combination product with a device constituent and the label of each device constituent part of a combination product to bear a UDI (with one narrow exception), and would have required the label of every convenience kit and the label of every device included in a convenience kit to bear a UDI.
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