How to place software version for SaMD product in HIBC secondary data structure (UDI-PI)?


Hi there,

We currently get stuck in how to assign UDI-PI for SaMD product and need some help.

We've already join HIBCC, so our UDI structure is planning under HIBC rule.
As we understood, 21 CFR 801.50 regulate that the UDI of stand-alone software should convey the version number in its PI,
however, we can not find a suitable flag or data identifier for version number.

In the manufacturing process, we would assign lot number for the product, which would be place in UDI-PI by flag $.
(the lot number is consist of the manufacturing date+2 digit sequence number.)

Could we place the software version number in serial number PI (by data identifier S)?


Involved In Discussions
FDA (nor do any regulatory body ) does not specify what it considers as the equivalent of a version number in the case of a Software Medical Device. It makes sense to use it with the data delimiter used for lot number per H1BCC standards (which I suppose is a $ symbol)
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