Hello All;
I am in the process of researching the UDI-DI compliance piece for our current product which is FDA Class 1. The guidance documents I am remaining call out that a UDI-DI is required for every version of product. We have a family of products which would be all be considered all "versions" of that product family line; however, does this requirement also stretch over into at what rev of each individual part is as well? I am leaning towards not, but I would like to hear what others think on the subject.
Thank you,
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Elizabeth Zak
Quality Engineer
Lumitex Inc.
Strongsville OH
United States
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