W
wangyang
Hi all:
We have product which will not and have never been to U.S.A market, since the FDA inspector will select device to review from 510(k) database when conducting field inspection, so we don't want to the never marketed device to be inspected by FDA, can we withdraw the cleared 510(k)?Do you know is there any procedure?
Thank you.
We have product which will not and have never been to U.S.A market, since the FDA inspector will select device to review from 510(k) database when conducting field inspection, so we don't want to the never marketed device to be inspected by FDA, can we withdraw the cleared 510(k)?Do you know is there any procedure?
Thank you.