An example of a combination product is a cell seeded scaffold, which is used to repair tissue damages. I believe that this product falls under the CBER regulation because it is designed to be therapeutic and aid in damaged tissue, which requires clinical testing before it can be used. The regulatory processes that needs to be done according to the CBER regulation is that it must follow the IND, (Phase 1,2,3) or Pivotal Trials, and BLA.