FDA ...CDVH office of device evaluation

[hoosierphilly]

Office of Device Evaluation




Director: William Maisel, M.D., M.P.H. (Acting) 301-796-5900
Deputy Director for Clinical Markham Luke, M.D., Ph.D. 301-796-5550
Deputy Director for Engineering & Science Review Jonette Foy, Ph.D. 301-796-5550
Deputy Director for Premarket Program Management Barbara Zimmerman 301-796-5550
Associate Director for Regulations and Guidance Angela Kruger 301-796-6341
Chief Medical Officer Randall Brockman, M.D. 301-796-6316
Clinical Trial Director Owen Faris, Ph.D. (Acting) 301-796-6356
Advisory Panel Coordinator James Swink 301-796-5550
Program Management Office Director Kathryn K. Appler 301-796-5560
Deputy Director, Program Management Office Sharyn (Lesa) A. Dowtin 301-796-5560
Premarket Approval Section Nicole Wolanski 301-796-5640
Investigational Device Exemption Section Soma Kalb, Ph.D. (Acting) 301-796-5640
Premarket Notification (510(k)) Section Marjorie Shulman 301-796-5640