| Office of the Center Director |
Center Director: |
Daniel G. Schultz, M.D. |
240-276-3939 |
Associate Director for Regulations and Policy |
Catherine Cook |
240-276-3939 |
Senior Associate Director |
Lillian J. Gill, DPA |
240-276-3939 |
| Associate Director for Postmarket Operations |
Jonathan Sackner-Bernstein |
240-276-3939 |
| Deputy Director for Postmarket Operations |
Diane Mitchell |
240-276-8851 |
Chief of Staff and Executive Officer |
Ruth E. McKee |
240-276-3939 |
Associate Director for Clinical Research & Govt Affairs |
Casper Uldriks |
240-276-3939 |
| Senior Policy Analyst |
Paul Fisher |
240-276-0585 |
Associate Director for Education and Communication |
Mark H. Barnett |
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: |
Frank Benedetti, Acting |
240-276-8876 |
Deputy Director |
Debbie Baclawski, Acting |
240-276-8867 |
Program Management Officer |
Joanna King, Acting |
240-276-8704 |
Division of Ethics and Management Operations |
Sandy Roderick |
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 |
Maria Boyreau, acting |
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 |
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 |
Recall Branch |
Rita Hoffman |
240-276-0130 |
Registration & Listing Forms |
Vacant |
|
Division of Bioresearch Monitoring |
Michael Marcarelli |
240-276-0125 |
Program Enforcement Branch |
Linda Godfrey |
240-276-0125 |
Special Investigations Branch |
Linda Godfrey, acting |
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 |
Erin Keith, Acting |
240-276-0120 |
Cardiovascular & Neurological Devices Branch |
William MacFarland |
240-276-0120 |
Orthopedic, Physical Medicine & Anesthesiology Devices Branch |
Anastacia Bilek, Acting |
240-276-0120 |
Radiology, Anesthesiology & Neurology Devices Branch |
Jennifer Medicus, Acting |
240-276-0120 |
| Vascular & Circulatory Support Devices |
Dorothy Lee, Acting |
240-276-0120 |
| Office of Device Evaluation |
Director: |
Donna Bea Tillman, Ph.D. |
240-276-3993 |
Deputy Director for Clinical |
Markham Luke, M.D., Acting |
240-276-3993 |
Deputy Director for Engineering and Science Review |
Christy Foreman, Acting |
240-276-3993 |
Associate Director |
Barbara Zimmerman, Acting |
240-276-3993 |
Integrity Officer |
Vacant |
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 |
Robert Gatling |
240-276-4040 |
Premarket Approval Section |
Nicole Wolanski |
240-276-4040 |
Investigational Device Exemption Section |
Stephen P. Rhodes |
240-276-4040 |
Premarket Notification (510(k)) Section |
Heather Rosecrans |
240-276-4040 |
Division of General, Restorative and Neurological Devices |
Mark Melkerson |
240-276-3737 |
Deputy Director I |
Neil R. Ogden, M.D., Acting |
240-276-3737 |
Deputy Director II |
Peter Rumm, M.D. |
240-276-3737 |
Plastic & Reconstructive Surgery Devices Branch |
David Krause |
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 |
Elizabeth Frank, Acting |
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 |
Vacant |
240-276-4000 |
Associate Director for Guidance and Policy |
Arthur A. Ciarkowski |
240-276-4000 |
Pacing, Defibrillator and Leads Branch |
Mitchell Shein, Acting |
240-276-4080 |
Cardiac Electrophysiology & Monitoring Devices Branch |
Elias Mallis |
240-276-4095 |
Interventional Cardiology Devices Branch |
Ashley Boam |
240-276-4222 |
Circulatory Support and Prosthetic Devices Branch |
Matthew Hillebrenner |
240-276-4266 |
Peripheral Vascular Devices Branch |
Kenneth Cavanaugh, Acting |
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 |
Clinical Deputy Director |
Eric Mann, M.D., Ph.D. |
240-276-4200 |
Associate Director |
Deborah Falls |
240-276-4200 |
Vitreoretinal & Extraocular Devices Branch |
Quyng Hoang, Acting |
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 |
Tina Kiang, Ph.D., Acting |
240-276-4242 |
Division of Reproductive, Abdominal, and Radiological Devices |
Janine Morris, Acting |
240-276-3636 |
Clinical Deputy Director |
Herbert Lener, 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 |
Ronald Jean, Ph.D., Acting |
240-276-4161 |
Gastroenterology and Renal Devices Branch |
Carolyn Neuland, Ph.D. |
240-276-4151 |
Radiological Devices Branch |
David Buckles, Ph.D., Acting |
240-276-3666 |
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices |
Chiu S. Lin, Ph.D. |
240-276-3700 |
Deputy Director |
Joy Samuels-Reid, M.D., Acting |
240-276-3700 |
Anesthesiology and Respiratory Devices Branch |
Lana Shiu, M.D., Acting |
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: |
Donald St. Pierre, Acting |
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 |
Associate Director for Policy and Operations |
Donald St. Pierre |
240-276-0378 |
| Chief Medical Officer |
Robert L. Becker, Jr., M.D. |
240-276-0843 |
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 |
Courtney C. Harper, Acting |
240-276-0694 |
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 |
Maria M. Chan, Ph.D., Acting |
240-276-0843 |
Associate Director for Immunology |
Maria M. Chan, Ph.D |
240-276-0843 |
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 |
Uwe Scherf, 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 |
Vacant |
|
| 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 |
Vacant |
|
| Product Evaluation Branch II |
Doug Wood, Acting |
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: |
Laurence W. Grossman, Ph.D., Acting |
301-796-2502 |
| 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 |
| 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 |
Dinesh Patwardhan, Ph.D. |
301-796-2475 |
| Division of Imaging and Applied Mathematics |
Kyle Myers, 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
|
|
Deputy Director
|
Heather D. Howell
|
240-276-3208
|
|
Assistant Director for
Program Operations
|
Clifford D. Evans
|
240-276-3211
|
|
Special Assistant to the
Director
|
Sharon Davis
|
240-276-3338
|
|
Staff College
|
Jacqueline Woodard
|
240-276-0977
|
|
Deputy Director
|
Joanne Choy, Acting
|
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
|
|
Associate Director
|
Alvin W. Thomas
|
240-276-3222
|
|
Risk Communication Branch
|
Vacant
|
|
| Web Communication Branch |
Laurel S. Mendelson |
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. Tartal
|
240-276-3230
|
|
Regulatory Assistance
Branch
|
Joseph V. Puleo
|
240-276-3230
|
|
International Relations
and External Affairs Staff
|
Carole C. Carey
|
240-276-3141
|
|
Division of
Communication Media
|
Chad Heupel
|
240-276-0900
|
|
Television Design and
Development Branch
|
Vacant
|
|
|
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
|
Nancy M. Wynne
|
240-276-3332
|
|
Diagnostic Devices Branch
|
Sean M. Boyd
|
240-276-3332
|
|
Electronic Products Branch
|
Robert Doyle
|
240-276-3332
|
