Hi Reg,
the numbered paragraph you referenced isn't product that has to be sold or has to be 'about to be sold' IMO. Could be release for some other proper IND purpose e.g. process validation after a new assay is added in.
In any case, there are ways around the strictures of Class 1 qualification IMO e..g. if the content of any new assay can be made the subject of a post-approval commitment, rather than a pre-approval demonstration.
And keep in mind numbered item 10.
All good
Cheers,
GLTA(LT)H
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