Though section 614 of the new American law does not mention Unique Device Identifiers as a requirement for certain software applications, I found a reference in Federal Register Vol. 77, No. 132 Tuesday July 10, 2012, Proposed Rules. The word device in the law covers certain software applications per § 201(h) of the FD&C Act.
From Page 40741
Ensuring the accurate identification of certain devices, even when the device is separated from its label and package. The rule would require some devices to be directly marked with a UDI, so that it will always be possible to positively identify the device, regardless of how long the device remains in use. These devices, by their intended or customary use, are typically separated from the labeling that accompanies delivery of the device to users:
• An implantable device;
• A device that is intended for more
than one use and to be sterilized before
each use; and
• Stand-alone software.
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