Surgical Mesh with Antibiotic coating is a combination product which can follow either CDRH or CDER regulatory guidelines. Based on my understanding the primary mode of action would to treat it as a class two medical device. But to verify that it should follow CDRH guidelines an RFD (request for designation) must be completed. If it is assigned to CDRH then it would require a Pre-market Notification (510K). Since this is a surgical device it will need clinical trials therefore an IDE must be completed. It would be classified as a class II device because it is not a life supporting or sustaining device. A surgical mesh can have substantial equivalence to a medical device previous to 1976. The claim of this device leads it to the pathway of class II regulations.