Another example of a combination product is a drug-eluting stent. This product can fall under CDER or CDRH guidelines. But a request for designation by the FDA would likely place this under CDRH jurisdiction since its primary mode of action is to act as a stent, which is a medical device. The secondary action of the device is to elute drug(s) to prevent restenosis. Because this stent is typically critical to maintenance of stenosed arteries, it would fall under Class III and require a PMA. Undoubtedly, because of its class III designation, a clinical trial would be required (IDE application).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=NIQ