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I am writing a Special 510k for a line extension for a size modification to an existing device. Some specifications that completed design verification for the predicate device really are not clinically necessary and were only for "nice to have". As these are not really applicable to the proposed device, do I need to include in the Special 510K?
Also, as this change is only to a new larger size which does not impact safety or effectiveness as the material is all that was validated for the predicate, can we just give a justification as to why design validation is not necessary?
Thanks
Also, as this change is only to a new larger size which does not impact safety or effectiveness as the material is all that was validated for the predicate, can we just give a justification as to why design validation is not necessary?
Thanks
