A collagen coated vascular prosthesis is considered a combination product. The product is used as a vascular graft and considered non-porous by coating it with a layer of collagen, taken from young calf skin. These grafts were implemented in the thoracic aorta and did not require special preparation time before implementation. I believe this type of product should be under the regulation of CDER since the product is made from a nonhuman resource. This product specifically will deal with human implementation and create an easy procedure that does not require special care for its use. It was able to suture easily and did not bleed. The bovine collagen was also reabsorbed completely in 90 days and replaced with native tissue. The tissue did not create any other issues in the body. The regulatory pathway should definitely fall under the CDER and undergo animal testing before it can be released into the market for its use.