There have are many instances when the device has dual capabilities which falls in both the CDRH and CDER but first we have to determine what the primary purpose for device for example its a antibiotic releasing hip stem than it primary purpose is to support hip rather than drug release so it first falls in CDRH class 2 medical device than we have to make sure it also complies to CDER for it’s antibiotic part. In this case it was simple to identify and classify your device. What if you cant classify your device Request of Designation (RFD) can be filled in which case FDA can identify for you and than you can adhere to all rules accordingly.