Dramatic story of how even the simplest medical devices require government approval

Someone please explain to me why it was necessary to get government approval for a simple tube that allowed this baby to breathe.  Fortunately, it was possible to clear this quickly, but why did they have to go through this process at all?  From Fox News:

. . . In the case of Kaiba Gionfriddo, doctors didn't have a moment to spare. Because of a birth defect, the little Ohio boy's airway kept collapsing, causing his breathing to stop and often his heart, too. Doctors in Michigan had been researching artificial airway splints but had not implanted one in a patient yet.In a single day, they "printed out" 100 tiny tubes, using computer-guided lasers to stack and fuse thin layers of plastic instead of paper and ink to form various shapes and sizes. 

The next day, with special permission from the Food and Drug Administration, they implanted one of these tubes in Kaiba, the first time this has been done. . . .