* An explanation of how stand-alone software can meet UDI labeling requirements when it is not distributed in packaged form (e.g., when it is downloaded from a labeler's Web site); such software need comply only with
* A requirement for all stand-alone software to include a means of displaying its UDI; stand-alone software that is distributed in packaged form must display a UDI on its label, device package, and on screen either upon startup or through a menu command;
* An explanation that stand-alone software that is distributed in both packaged form and in a form that is not packaged (e.g., when downloaded from a Web site) may be identified with the same device identifier.
FDA believes that
BB. Request for an Exception From or Alternative to a Unique Device Identifier Requirement--Proposed
FDA received many comments (approximately 29) concerning this section. When proposed, this section was titled, "Request for an exception from or alternative to the requirement for a device to bear a unique device identifier."
Most of the comments on this section were concerned with various aspects of the process outlined in the proposed rule, and sought more clarity concerning the process, including timeframes, feedback, decisions, and appeals. A typical comment stated, "The procedure should include: Upon receipt and approval of an exemption request,
FDA agrees that some categorical exceptions are useful, and the final rule provides several; see
A few comments suggested
FDA agrees. We intend to make each
One comment suggested a request should be "deemed" accepted if
FDA disagrees. There may be many valid reasons why
Two comments asked that a trade association be permitted to file a request for an exception or alternative.
FDA believes it is preferable for each request to be initiated by a labeler, but we have no objection if a trade association submits its views at the request of that labeler. The final rule has not been modified to permit a trade association to initiate a request.
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