We have a Class II (510(k) exempt) device, currently listed under a given product code.
I'm now looking at other ProCodes and have found one that is an even more accurate description of the device. Trouble is, it is a different class (Class I).
Questions:
1. How onerous is it to change a product code (assuming it can be done)?
2. Can it be done if the classification changes (Class II -> Class I)? (note: no 510(k) is involved, as the original procode is 510(k) exempt)
I'm now looking at other ProCodes and have found one that is an even more accurate description of the device. Trouble is, it is a different class (Class I).
Questions:
1. How onerous is it to change a product code (assuming it can be done)?
2. Can it be done if the classification changes (Class II -> Class I)? (note: no 510(k) is involved, as the original procode is 510(k) exempt)