F
Frodeno
Hi Everyone,
Long time lurker, first time poster. I have a question that I thought I would put to the collective wisdom of the group. I realize that this question is not directly relating to the standard but also to the FDAs guidance document so this may not be the appropriate forum for the question.
So, I am preparing a 510(k) submission for a device that has been used in the EU for several years. Management do not want to spend the $$ to conduct a U.S. based useability study and instead want to leverage the years of experience with EU doc/users. FDA guidance recommends that testing should be carried out with U.S. based users for devices to be marketed in the U.S.
Does anyone have any experience trying to leverage such non-U.S. based data ? any guesses on chances of success with an examiner ?
Thanks,
Frodo
Long time lurker, first time poster. I have a question that I thought I would put to the collective wisdom of the group. I realize that this question is not directly relating to the standard but also to the FDAs guidance document so this may not be the appropriate forum for the question.
So, I am preparing a 510(k) submission for a device that has been used in the EU for several years. Management do not want to spend the $$ to conduct a U.S. based useability study and instead want to leverage the years of experience with EU doc/users. FDA guidance recommends that testing should be carried out with U.S. based users for devices to be marketed in the U.S.
Does anyone have any experience trying to leverage such non-U.S. based data ? any guesses on chances of success with an examiner ?
Thanks,
Frodo