The necessary steps to take in order for a combination product to get FDA approval is to first find out what is the main purpose of the product itself. I just want to highlight how important it is for a product to identify its main functional requirement. There were a couple of examples from lecture of how there can be a different combination of Drugs, Devices, and Biologics. To recall, there could be a drug that’s injected by a syringe. It’s main rationale would most likely be the drug because of its metabolic effect. Another would be a antibiotic coated hip stem. The main rationale of this would be the hip stem, because at the end of the day it is a physical device meant to provide structural support.

It’s very important that the company stipulate what category it would fall under when submitting the RFD to the Office of Combination Products. Once their designation is determined, it is binding. This could cause difficulty to companies who aren’t very familiar with Drugs or Biologics if their reputation is primarily in devices. Any decision can be appealed to Ombudsman.

All steps whether it’s a Drug, Biologic, or Device can be highlighted from what djr32 shared. The end goal for a Drug is to get an NDA approval, a biologic is to get a BLA approval, and a device is to get a 510k or PMA.