I don't know the implications of this. All I know is that I feel very safe using FDA approved bedpans and shower curtains. Slowing down the process for devices will be a double-edged sword - much like the one we are already used to.... It may save us from inappropriate use of unproven technology, and it also may keep us from gaining access to the life-saving technology that we truly need.
A crystal ball (one that tells the truth) would certainaly be useful here!
Mark
|