FDA believes it is the responsibility of each labeler to determine the most appropriate date to use for each specific device, and to be consistent in application of that policy.
A comment suggested that stand-alone software should be able to use its version number as its production identifier.
We agree that for stand-alone software, the version number falls within the meaning of lot or batch, which is one type of production identifier. Therefore, when the labeler of stand-alone software includes a version number on the label, it must be conveyed by the production identifier. Further, because it is important for the version number to be included in stand-alone software that is not distributed in packaged form, we are adding a requirement to
Universal product code (UPC) --We did not receive any comments concerning this definition, but we have included a minor edit in the definition used in the final rule. The revised definition refers only to identification of "an item sold at retail in
Version or model --A comment stated: "The definition says that version or model means a package. This is not easy to follow because version or model normally refers to a device."
FDA agrees. The final rule adopts a definition that we believe is clearer and better reflects the common understanding of this term. The final rule removes the reference to a "device package." The final rule defines version or model to mean "all devices that have specifications, performance, size, and composition, within limits set by the labeler."
Undefined terms --A few comments suggested that additional terms should be defined to clarify the scope and intent of the rule. For example, a few comments stated that
Although the proposed rule did not provide a definition of "device," none is required. "Device" is defined by statute, (see section 201(h) of the FD&C Act (21 U.S.C. 321(h)), has been in common use for decades, and has been a core concept inherent in every medical device regulation ever issued. Its meaning should be clear to every person affected by this rule. This rule does not require any further definition or clarification of this term, and the final rule does not include a definition of "device."
Another comment suggested
FDA disagrees. Section 201(h) of the FD&C Act makes clear that the term "device" includes an accessory. No other medical device regulation has defined "accessory" (the term is defined within the context of radiological health; see 21 CFR 1020.30(b)), and the final rule does not include any requirement that specifically applies only to an accessory to a device and does not distinguish between accessories and other devices in any way.
A comment pointed out that
We believe the meaning of this phrase is made clear by the language of
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