| Office of the Center Director |
| Center Director: |
Daniel G. Schultz, M.D. |
240-276-3939 |
| Deputy Director |
Linda S. Kahan |
240-276-3939 |
| Senior Associate Director |
Lillian J. Gill, DPA |
240-276-3939 |
| Associate Director for Clinical Research & Govt Affairs |
Vacant |
240-276-3939 |
| Associate Director for Management & Systems |
Ruth E. McKee |
240-276-3900 |
| CIO’s Office of Information Technology CDRH |
Michele Hudson, Acting |
240-276-0501 152 |
| Deputy Director |
Vacant |
240-276-0501 |
| Software & Web Development Branch |
Michael Coene |
240-276-0602 |
| Assistant Director for Education and Communication |
Mark H. Barnett |
240-276-3939 |
| Director, Executive Services |
Lily Ng |
240-276-3939 |
| Ombudsman/Quality Assurance Manager |
Les S. Weinstein |
240-276-3939 |
| Director, Medical Device Fellowship Program |
Nancy J. Pluhowski |
240-276-3816 |
| Office of Management Operations |
| Director: |
Ruth E. McKee |
240-276-3900 |
| Associate Director for Management |
Sandra G. Cordes |
240-276-3900 |
| White Oak Planning Coordinator |
Frank Benedetti |
240-276-8876 |
| Program Management Officer |
Debra Baclawski |
240-276-8867 |
| Division of Ethics and Management Operations |
Sandy Roderick-Rudden |
240-276-8899 |
| Deputy Director |
M. Shannon Gipson |
240-276-8898 |
| Occupational Health and Safety Officer |
Tom Vegella |
301-796-2783 |
| Administrative Management Branch |
Debra Grygier |
240-276-8944 |
| Integrity, Committee and Conference Management Branch |
Kathleen Walker |
240-276-8938 |
| Freedom of Information Branch |
Joy Lazaroff |
240-276-8903 |
| Division of Planning, Analysis, & Finance |
Patric Baumgartner |
240-276-8880 |
| Deputy Director |
Maria Boyreau |
240-276-8891 |
| Planning Branch |
Marjorie Waskewich |
240-276-8870 |
| Analysis Branch |
Bonnie Markovitz |
240-276-8924 |
| Financial Management Branch |
Tracey Hill |
240-276-8926 |
| Office of Compliance |
| Director: |
Timothy A. Ulatowski |
240-276-0100 |
| Deputy Director for Regulatory Affairs |
Larry Spears |
240-276-0100 |
| Deputy Director for Medical Affairs |
Kimber Richter |
240-276-0105 |
| Special Assistant |
Bryan H. Benesch |
240-276-0100 |
| Promotion and Advertising Policy Staff |
Ann Simoneau |
240-276-0100 |
| Program Management Officer |
Collin L. Figueroa |
240-276-0228 |
| Division of Risk Management Operations |
Karen L. Moss |
240-276-0130 |
| Deputy Director |
Joanna Weitershausen |
240-276-0130 |
| Field Programs Branch |
Allen Wynn |
240-276-0130 |
| Regulatory Policy and Systems Branch |
Theresa McDonald |
240-276-0219 |
| Risk Management and Analysis Branch |
|
240-276-0130 |
| Registration & Listing Forms |
|
240-276-0110 |
| Division of Bioresearch Monitoring |
Michael Marcarelli |
240-276-0125 |
| Program Enforcement Branch |
Doreen Kezer |
240-276-0125 |
| Special Investigations Branch |
Linda Godfrey |
240-276-0125 |
| Division of Enforcement A |
Betty W. Collins |
240-276-0115 |
| Deputy Director |
George Kroehling |
240-276-0115 |
| Dental, ENT and Ophthalmic Devices Branch |
Ronald L. Swann |
240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch |
Paul Tilton |
240-276-0115 |
| General Hospital Devices Branch |
Valerie Flournoy |
240-276-0115 |
| General Surgery Devices Branch |
Thomas Knott |
240-276-0115 |
| Division of Enforcement B |
Gladys Rodriguez |
240-276-0120 |
| Deputy Director |
Christy Foreman |
240-276-0120 |
| Cardiovascular & Neurological Devices Branch |
Nicole Wolanski |
240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Branch |
William MacFarland |
240-276-0120 |
| Office of Device Evaluation |
| Director: |
Donna Bea Tillman, Ph.D. |
240-276-3993 |
| Deputy Director for Clinical |
Aron Yustein, M.D. |
240-276-3993 |
| Deputy Director for Engineering and Science Review |
Ashley Boam, Acting |
240-276-3993 |
| Associate Directory |
Robert Gatling, Acting |
240-276-3993 |
| Integrity Officer |
Carl T. DeMarco, R.Ph., J.D. |
240-276-3993 |
| Advisory Panel Coordinator |
Geretta Wood |
240-276-3993 |
| Program Management Office |
Kathryn K. Appler |
240-276-4004 |
| Deputy Director |
Sharyn (Lesa) A. Dowtin |
240-276-4004 |
| Program Operations Staff |
Heather Rosencrans, Acting |
240-276-4040 |
| Premarket Approval Section |
Samie Allen, Acting |
240-276-4040 |
| Investigational Device Exemption Section |
Stephen P. Rhodes |
240-276-4040 |
| Premarket Notification (510(k)) Section |
Marjorie Shulman, Acting |
240-276-4040 |
| Division of General, Restorative and Neurological Devices |
Mark Melkerson |
240-276-3737 |
| Deputy Director I |
Barbara Buch, M.D. |
240-276-3737 |
| Deputy Director II |
Peter Rumm, M.D. |
240-276-3737 |
| Plastic & Reconstructive Surgery Devices Branch |
David Krause, Acting |
240-276-3555 |
| General Surgery Devices Branch |
Neil R. Ogden |
240-276-3600 |
| Orthopedic Joint Devices Branch |
Jonette Foy, Ph.D. |
240-276-3676 |
| Orthopedic Spine Devices Branch |
Theodore Stevens |
240-276-3676 |
| Restorative Devices Branch |
Laurence Coyne |
240-276-3575 |
| Division of Cardiovascular Devices |
Bram D. Zuckerman, M.D. |
240-276-4000 |
| Deputy Director I |
Donna Lochner |
240-276-4000 |
| Deputy Director II |
Barbara Zimmerman |
240-276-4000 |
| Associate Director for Guidance and Policy |
Arthur A. Ciarkowski |
240-276-4000 |
| Pacing, Defibrillator and Leads Branch |
Megan Moynahan |
240-276-4080 |
| Cardiac Electrophysiology & Monitoring Devices Branch |
Elias Mallis |
240-276-4095 |
| Interventional Cardiology Devices Branch |
Kenneth Cavanaugh, Acting |
240-276-4222 |
| Circulatory Support and Prosthetic Devices Branch |
Matthew Hillebrenner |
240-276-4266 |
| Peripheral Vascular Devices Branch |
David Buckles, Ph.D. |
240-276-4141 |
| Division of Ophthalmic and ENT Devices |
Malvina Eydelman, M.D. |
240-276-4200 |
| Deputy Director |
Everette Beers, Ph.D. |
240-276-4200 |
| Associate Directory |
Deborah Falls |
240-276-4200 |
| Vitreoretinal & Extraocular Devices Branch |
James Saviola, O.D. |
240-276-4232 |
| Intraocular and Corneal Implants Branch |
Kesia Alexander, Ph.D. |
240-276-4252 |
| Diagnostic and Surgical Devices Branch |
Kwame Ulmer |
240-276-4262 |
| Ear, Nose, and Throat Devices Branch |
Eric Mann, M.D., Ph.D. |
240-276-4242 |
| Division of Reproductive, Abdominal, and Radiological Devices |
Nancy C. Brogdon |
240-276-3636 |
| Clinical Deputy Director |
Herbert Lemer, M.D. |
240-276-3636 |
| Scientific Deputy Director |
Joyce Whang, Ph.D. |
240-276-3636 |
| Obstetrics/Gynecology Devices Branch |
Colin M. Pollard |
240-276-4100 |
| Urology and Lithotripsy Devices Branch |
Janine Morris |
240-276-4161 |
| Gastroenterology and Renal Devices Branch |
Carolyn Neuland, Ph.D. |
240-276-4151 |
| Radiological Devices Branch |
Anastacia Bilek, Ph.D. |
240-276-3666 |
| Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices |
Chiu S. Lin, Ph.D. |
240-276-3700 |
| Deputy Director |
Ginette Michaud, M.D. |
240-276-3700 |
| Anesthesiology and Respiratory Devices Branch |
Michael Husband |
240-276-3775 |
| General Hospital Devices Branch |
Anthony D. Watson |
240-276-3707 |
| Infection Control Devices Branch |
Sheila Murphey, M.D. |
240-276-3747 |
| Dental Devices Branch |
M. Susan Runner, D.D.S. |
240-276-3773 |
| Office of In Vitro Diagnostic Device Evaluation and Safety |
| Director: |
Steven I. Gutman, M.D. |
240–276–0375 |
| Deputy Director, New Product Evaluation |
Alberto Gutierrez, Ph.D. |
240–276–0376 |
| Deputy Director, Patient Safety and Product Quality |
James L. Woods |
240-276-0377 |
| Scientific Policy Advisor |
Sousan S. Altaie, Ph.D. |
240-276-0378 |
| Program Management Officer |
David R. Warren |
240-276-0392 |
| Division of Chemistry and Toxicology Devices |
Jean Cooper, DVM |
240-276-0395 |
| Associate Director for Chemistry |
Carol C. Benson |
240-276-0396 |
| Associate Director for Toxicology |
Courtney C. Harper, Ph.D. |
240-276-0694 |
| Division of Immunology and Hematology Devices |
Robert L. Becker, Jr., M.D. |
240-276-0843 |
| Associate Director for Immunology |
Maria M. Chan, Ph.D. |
240-276-0848 |
| Associate Director for Hematology |
Josephine M. Bautista |
240-276-0847 |
| Division of Microbiology Devices |
Sally A. Hojvat, Ph.D. |
240-276-0711 |
| Associate Director for Bacteriology |
Freddie M. Poole |
240–276–0712 |
| Associate Director for Virology |
Scherf, Uwe, Ph.D. |
240-276-0725 |
| Office of Surveillance and Biometrics |
| Director: |
Susan N. Gardner, Ph.D. |
240-276-3351 |
| Deputy Director |
Stephen M. Sykes |
240-276-3408 |
| Issues Management Staff |
Patricia Kingsley, Director |
240-276-3370 |
| Program Management Office |
Donna Schwartz |
240-276-3352 |
| Patient Safety Staff |
Marilyn Flack, Director |
240-276-2391 |
| Division of Postmarket Surveillance |
Thomas P. Gross, M.D. |
240-276-3419 |
| Deputy Director |
Steven Chasin, Ph.D. |
301-594-3674 |
| Product Evaluation Branch I |
Cara J. Krulewitch |
240-276-2291 |
| Product Evaluation Branch II |
Sonia Swayze |
240-276-3425 |
| Epidemiology Branch |
Danica Marinac-Dabic, Ph.D., M.D. |
240-276-2367 |
| Division of Surveillance Systems |
David S. Shindell, Ph.D. |
240-276-3445 |
| Deputy Director |
Mary Weick-Brady |
240-276-3458 |
| Systems Support Branch |
Indira Konduri |
240-276-3459 |
| Reporting Systems Monitoring Branch |
Sharon Kapsch |
240-276-3471 |
| Division of Biostatistics |
Greg Campbell, Ph.D. |
240-276-3133 |
| Deputy Director |
Kay Barrick |
240-276-3109 |
| Chief, Cardiovascular and Ophthalmic Devices Branch |
Lilly Yue |
240-276-3163 |
| Chief, Diagnostic Devices Branch |
Lakshmi Vishnuvajjala |
240-276-3171 |
| Chief, General Surgical Devices Branch |
Telba Irony |
240-276-3169 |
| Office of Science and Engineering Laboratories |
| Director: |
Larry Kessler, Sc.D. |
301-796-2781 |
| Deputy Director for Science and Strategic Initiatives |
William A. Herman |
301-796-2781 |
| Deputy Director for Program Policy and Evaluation |
Subhas Malghan, Ph.D. |
301-796-2781 |
| Associate Director for Compliance Activities |
Thomas Lee |
301-796-2554 |
| Associate Director for Laboratories |
Charles Warr |
301-796-2556 |
| Outreach Coordinator |
Ann Mastradone |
301-796-2560 |
| Director, Standards Management Staff |
Carol Herman |
240-276-0556 |
| Director, Management Support Staff |
Angie Clingerman |
301-796-2569 |
| Division of Biology |
Marilyn M. Lightfoote, M.D. |
301-796-0235 |
| Deputy Director |
Melvin E. Stratmeyer, Ph.D. |
301-796-0261 |
| Deputy Director |
John J. Langone, Ph.D. |
301-796-0245 |
| Division of Physics |
Joel Myklebust, P.E., Ph.D. |
301-796-2491 |
| Deputy Director |
Brian Beard |
301-796-2469 |
| Division of Solid and Fluid Mechanics |
Laurence W. Grossman, Ph.D. |
301-796-2502 |
| Deputy Director |
Jon Casamento |
301-796-2499 |
| Division of Chemistry and Materials Science |
Steven Pollack, Ph.D. |
301-796-2476 |
| Deputy Director |
Joyce Whang, Ph.D. |
301-796-2475 |
| Division of Imaging and Applied Mathematics |
David G. Brown, Ph.D. |
301-796-2562 |
| Deputy Director |
Nicolas Petrick, Ph.D. |
301-796-2563 |
| Division of Electrical and Software Engineering |
Alford Taylor, Jr. |
301-796-2583 |
| Deputy Director |
Brian Fitzgerald |
301-796-2579 |
| Office of Communication, Education, and Radiation Programs |
| Director: |
Lynne L. Rice |
240-276-3200 |
| Deputy Director |
John L. McCrohan |
240-276-3200 |
| Assistant Director for Program Operations |
Clifford D. Evans |
240-276-3211 |
| Special Assistant to the Director |
Heather D. Howell |
240-276-3338 |
| Staff College |
Renee A. Brotman |
240-276-0977 |
| Deputy Director |
Simon Choi |
240-276-0977 |
| Regulations Staff |
Deborah Wolf |
240-276-2350 |
| Division of Device User Programs and Systems Analysis |
Jay A. Rachlin |
240-276-3222 |
| Deputy Director |
Margaret T. Tolbert |
240-276-3222 |
| Human Factors Engineering Branch |
Vacant |
240-276-3222 |
| Outreach and Public Participation Branch |
Alvin W. Thomas |
240-276-3222 |
| Division of Small Manufacturers, International and Consumer Assistance |
John F. Stigi |
240-276-3141 |
| Deputy Director |
William Sutton |
240-276-3141 |
| Technical Assistance Branch |
Joseph V. Puleo |
240-276-3141 |
| Regulatory Assistance Branch |
Thomas E. Cardamone |
240-276-3141 |
| International Relations and External Affairs Staff |
Carole C. Carey |
240-276-3141 |
| Division of Communication Media |
Robert F. McCleary |
240-276-0900 |
| Television Design and Development Branch |
Vacant |
240-276-0900 |
| Division of Mammography Quality and Radiation Programs |
Helen J. Barr, M.D. |
240-276-3332 |
| Deputy Director |
Thomas R. Ohlhaber |
240-276-3332 |
| Associate Director for Policy and Clinical Affairs |
Charles A. Finder, M.D. |
240-276-3332 |
| Associate Director for Administration |
Kathleen M. Sheridan |
240-276-3332 |
| Accreditation and Certification Branch |
Kathleen A. Franke |
240-276-3332 |
| Radiation Programs Branch |
Petro Shandruk |
240-276-3332 |
| Information Management Branch |
Timothy J. Haran |
240-276-3332 |
| Inspection and Compliance Branch |
Michael P. Divine |
240-276-3332 |
| Diagnostic Devices Branch |
Thomas M. Jakub |
240-276-3332 |
| Electronic Products Branch |
Sean M. Boyd |
240-276-3332 |
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