There is a labeling requirement to limit certain hearing MDs to 18-year-olds. in software labeling, does anyone have experience in how accurate is the necessary age calculation? In other words, how is the tolerance for the definition of 18 yo? currently, we limit the calculation using the birth year, this obviously has a possible error of up 364 days or 11 months below the definition of older than 18. The device is Class I.
I'll appreciate any idea.
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M Alonso-Amigo PHD,MBA
Getafe CA
Spain
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