> The US has to be sure it’s completely safe. That doesn't make sense to me, who does US refer to in this case? The manufacturer is the one that would be sued

> The US has to be sure it’s completely safe. That doesn't make sense to me, who does US refer to in this case? The manufacturer is the one that would be sued and they generally only want to expediate process. FDA is one that aproves/denies application. They wouldn't get sued for using data from other countries (or at least no more that they already are).