A comment suggested that the rule require direct marking with "only one of the four production identifiers."
FDA disagrees. The full UDI is necessary for precise identification of the device. For example, if a recall applies to only one lot or batch, it would not help if the direct marking omitted that information and instead provided only an expiration date that applies to several lots--it would not be possible to distinguish only devices subject to the recall from other devices that are not subject to the recall. Accordingly, a device required to be directly marked under
Z. Devices That Must Be Directly Marked With a Unique Device Identifier--Proposed Requirement for Submission of a Notice to FDA Upon Determining That an Exception Applies--Proposed
FDA received several comments (approximately 13) concerning this proposed requirement. These comments showed that the proposed requirement was unclear and unlikely to be useful. For example, a comment observed that
FDA agrees that this notice is not necessary. We do not require a notice to
AA. Special Requirements for Stand-Alone Software--Final
The proposed rule included stand-alone software among the types of devices that would have been subject to proposed
A comment asked how the requirement for AIDC would apply to cloud software (software as a service), and the same question can be extended to any software that is not distributed in packaged form, for example, when downloaded from a Web site.
Under SEC 801.50(a) of the final rule, stand-alone software that is not distributed in packaged form (e.g., when downloaded from a Web site) is deemed to meet all UDI labeling requirements if the software provides its UDI in a manner specified by
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