VCOM Institutional Policy and Procedure Manual

7. The IRB will determine if the approved device is intended for new indications based on the following criteria: a. Different age population b. New disease or condition c. Different body placement d. Changing intended use from treatment to prevention for the same disease 8. The IRB will review the intended use of approved devices to determine if a new IDE is warranted. a. The IRB Coordinator will locate the FDA labeling through the 510(k) clearance number or the Postmarket Approval (PMA) number b. The IRB Coordinator will provide this information to the IRB for review 9. The IRB Coordinator will document the IRB’s determination of risk and IDE requirements in the meeting minutes and any applicable case files. D URATION OF P OLICY The VCOM Procedure on Review of Investigational Device Protocols established by the Institutional Review Board is effective as of the date above and shall remain effective until amended or terminated by the President and the Dean. 7.