We are planning to develop a new medical device of which there is no predicate device available. It uses a technology of which we are not sure if the FDA will allow it to be used (I apologize for not giving any details but you will understand this is confidential).
If we would be 100% sure that FDA will reject a device with this technology, we would not invest the development cost. Are there ways to find out upfront what FDA's opinion would be about using the technology (without giving an opinion on the eventual product of course)?
If we would be 100% sure that FDA will reject a device with this technology, we would not invest the development cost. Are there ways to find out upfront what FDA's opinion would be about using the technology (without giving an opinion on the eventual product of course)?