Combination products. The FDA has definitions for what constitutes a drug, a biologic, and a medical device. However, there are times when marketing approval is sought for products that combine two or more of these, such as skin patches that deliver drugs or drug eluting stents. These products are referred to as combination products.

For this week’s writing assignment, you will write a one-two page description on how to determine if a product is a combination or non-combination product and the process you would go through to determine what a company should focus on during the approval phase.

The following is a little more information to get you started: You are working at a company that is in the process of trying to market a new product and your fellow colleagues in the regulatory department are unsure of how FDA will view the company’s product. The job of determining what the company should do has now fallen on you since your boss thinks you are the best employee in regulatory. How would you go about determining if the product is a combination-product or not? Assuming it is a combination product what guidances should the company you work for pay close attention to?