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FDA Class 1 Medical Device UDI requirements


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I have not found much information on Class 1 minimum requirements. I know the UDI contains the DI and PI but to what extent. Also we make product that could have a blue color, or a red, or a green, does that mean I need a separate UDI for all different colors and options? Just seems overkill if it still all under the same product family. Does anyone have an example or could send me in the right direction?


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Correct and I have looked there. When you go to gs1 they compare how many barcodes I will need to t shirt with sizes and colors. I find it hard to believe I will need 10s of thousands of barcodes for the 15 products we have then. I don't see how I will need a bar code for a product that we offer in 20 colors? that's already now 300 barcodes, then also add in bar codes for the different options of a headrest lets say 7 that's just the begining. Just doesn't make sense.

I can see a barcode for a product if there is a size or voltage difference but not colors, or simple options.


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Regarding Class 1, I have been advised that the PI is not required on a class 1 product, that a UPC will meet UDI requirements.
Also refer to 21 CFR 801.30 (11) (d).
It is voluntary if you wish to add it.
if you are asking does a class I medical device need registration and Device Listing. the answer is yes. If you are asking about UDI labels, see the link above for the compliance dates for Class I and unclassified devices. It is my understanding that if you have a class I device and it does not require GMP then it will not require a UDI when the compliance date arrives (currently September 2020). Hope this helps.
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