VCOM Institutional Policy and Procedure Manual

Edward Via Virginia College of Osteopathic Medicine

Effective Date: May 18, 2010

Signature on File ____________________________ Dixie Tooke-Rawlins, D.O. Dean and Executive Vice President

Signature on File ____________________________ James F. Wolfe, Ph.D. President ___________________________________________________________________________________________

VCOM Procedure on Review of Investigational Device Protocols ____________________________________________________________________________________

1. P URPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the process of review for investigational device protocols to be followed by the VCOM IRB, in order to make the risk determination, significant/non-significant and aid in the compliance with FDA regulation. S COPE This SOP applies to all VCOM IRB submissions which involve investigational devices, to include those approved by the FDA with investigational device exemption (IDE), or non-significant risk device studies. R ESPONSIBILITY The IRB Chair Person, and in the absence of Chair Person, the Co-Chair Person, will designate the type of review required, and if expedited will designate the appropriate IRB members to conduct the view process, based on the type of proposed device and associated risk. This SOP must be reviewed annually by the Associate Vice President for Research This SOP must be reviewed annually by the Associate Vice President for Research. R EGULATIONS To ensure the compliance with human subject protections requirements, VCOM IRB will conduct a review in accordance with and under the authority of HHS regulations, 45 CFR 46 and FDA regulations, 21CFR 56, and specifically: 21 CFR 812 Investigational device exemptions 201(h) Federal Food Drug & Cosmetic (FD&C) Act 2. 3. 4.