`Food and Drug Act polymer restrictions (medical devices)`

When we come to material selection, another externality, particularly in medical materials, is in the early 1970s Congress passed the law enacting the Food and Drug Act, and they said we will grandfather any material that's already been used as an implant in the human body, but if you're going to bring in a new material, since we're dealing with humans here, we're going to make you qualify it. Since then, to my knowledge there has never been another material qualified for use in the human body, other than the materials that existed before the 1970s. Because no one wants to spend the hundreds of millions of dollars in all the dog studies and then a human study.