This message was posted by a user wishing to remain anonymous
I am looking for some consultancy help from a qualified Toxicologist who has experience with FDA 510k submissions.
The product is an electrical muscle stimulator (product code NGX) and am hoping to find someone with specific the experience with these devices. I have used a European based Toxicologist previously but have found the lack of direct experience in dealing with the FDA to be a disadvantage..
Best regards