Many products that the U.S. Food and Drug Administration (FDA) regulates are not just drugs, devices, or biological products, but rather, are a combination of these regulated products. The FDA’s Office of Combination Products (OCP) is responsible for assigning an FDA Center to evaluate and review combination products. This assignment may mean the difference between having the product evaluated as a new drug to be submitted through the New Drug Application (NDA) process, or require a medical device 510(k) clearance. Appropriately identifying the product designation at the beginning of the submission process and filing the appropriate application can avoid significant delays and costs to a corporation that is looking to get their product into the marketplace.
Fuerst Ittleman has experience working with the OCP and preparing requests for designation (RFD) to help clients gain a more advantageous designation. We can help your business determine if your product is a combination product. If your product is a combination product, we can draft RFDs and correspond with OCP on your behalf to persuade the FDA to adopt the most appropriate designation for your business model and goals. If your product is not a combination product, please see our drug, medical device and biological products pages to learn more about FI’s experience with these products.
For further information on how Fuerst Ittleman can help your company with combination products, please contact us at (305) 350-5690 or contact@fuerstlaw.com.
