Combination product is a product composed of any combination (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic). Infuse bone graft is a combination product which consists a protein that is found in everyone’s body and a natural carrier for delivery. Infuse bone graft eliminates the need for the harvest surgery, avoiding the pain associated with the bone harvest procedure. It would be classified as a class III device because it sustains or supports life present potential unreasonable risk of illness or injury. Depending on the nature of a tissue engineered product can be assigned to CBER or CDRH and required PMA. Company must submit RFD request for designation to FDA. Through “Pre” pre-IDE process interact with FDA that allows developers to obtain initial feedback of preclinical and clinical testing that necessary which can saves time and cost. Clinical animal studies for IDE trial written by clinical department; however, regulatory guides through this process. Last regulatory assembles information for PMA’s and entire team.