We broadened the scope of proposed
A comment recommended that direct markings need to be "as permanent as the normal life expectancy" of the device, and need to be "capable of withstanding the normal usage and cleaning procedures" specified for the device.
FDA agrees that this is a reasonable approach, but we do not believe it is appropriate to specify any particular approach in the rule, because it would be difficult to define "normal" usage or "normal" cleaning procedures for all devices, and technological advancements may change what constitutes normal usage and appropriate cleaning procedures.
A comment stated that direct marking is "appropriate" for single-use sterilized devices, as well as for all devices intended for more than one use.
FDA disagrees that reprocessed single-use devices should be directly marked because, by definition, the device is originally intended only for a single-use. Direct marking is necessary to be able to identify and locate devices subject to reprocessing in case of problems with the reprocessing.
A comment stated, "to the extent practical, direct marking of reusable devices should occur" but also noted, that there "may be some products where size would prohibit direct marking with a UDI." Another comment suggested that direct marking may interfere with sterilization of small devices.
FDA has not been presented with any data that shows a correlation between the size of a device marked with a UDI or similar mark and ineffective sterilization or reprocessing. Accordingly,
A comment suggested that direct marking be required for all devices tracked under part 821, without exception.
FDA disagrees. A device tracked under part 821 is subject to controls that are specifically designed to take into account the particular characteristics and uses of that device, and the tracking requirements that apply to that device will ensure adequate identification of the device throughout its distribution and use.
A comment suggested that a reprocessor of a single-use device should not be permitted to display any form of the original UDI.
FDA disagrees. Section 830.60 requires that a relabeled device have a new UDI; therefore it would not be permissible to display the original UDI on the label or device package of the reprocessed device.
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