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About FDA
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CDRH Management Directory by Organization
This information is current as of November 17, 2009
| Office of the Center Director | ||
| Center Director: | Jeffrey Shuren, M.D., J.D. (acting) | 301–796–5900 |
| Associate Director for Regulations and Policy | Vacant | 301–796–5900 |
| Senior Associate Director | Lillian J. Gill, DPA | 301-796-5900 |
| Associate Director for Postmarket Operations | Jonathan Sackner-Bernstein | 301-796-5420 |
| Deputy Director for Postmarket Operations | Diane Mitchell | 301-796-5423 |
| Associate Director for Management and Executive Officer | Ruth E. McKee | 301-796-5900 |
| Associate Director for Clinical Research & Govt Affairs | Casper Uldriks | 301-796-5447 |
| Senior Policy Analyst | Paul Fisher | 301-796-6176 |
| Ombudsman/Quality Assurance Manager | Les S. Weinstein | 301-796-5699 |
| Director, External Expertise and Partnerships | Nancy J. Pluhowski | 301-796-5696 |
| Program Management Officer | Joanna King | 301-796-5929 |
| Office of Management Operations | ||
| Director: | Frank Benedetti | 301-796-5449 |
| Deputy Director | Debbie Baclawski | 301-796-5757 |
| Program Management Officer | Joanna King | 301-796-5929 |
| Division of Ethics and Management Operations | Sandy Roderick-Molina | 301-796-5970 |
| Deputy Director | Shannon Gipson | 301-796-5968 |
| Occupational Health and Safety Officer | Tom Vegella | 301-796-2783 |
| Administrative Management Branch | Howard Goldstein, (acting) | 301-796-5933 |
| Integrity, Committee and Conference Management Branch | Kathleen Walker | 301-796-5964 |
| Freedom of Information Branch | Joy Lazaroff | 301-796-5946 |
| Division of Planning, Analysis, & Finance | Maria Boyreau, Director | 301-796-5984 |
| Deputy Director | Marjorie Waskewich | 301-796-5989 |
| Planning Branch | Daniel Montgomery, (acting) | 301-766-5987 |
| Analysis Branch | Bonnie Markovitz | 301-796-5972 |
| Financial Management Branch | Tracey Hill | 301-796-5976 |
| Office of Compliance | ||
| Director: | Timothy A. Ulatowski | 301-796-5500 |
| Deputy Director for Regulatory Affairs | Larry Spears | 301-796-5500 |
| Deputy Director for Medical Affairs | Kimber Richter | 301-796-5500 |
| Program Management Officer | Collin L. Figueroa | 301-796-5500 |
| Quality Management Staff | Frances Benedict | 301-796-5500 |
| Division of Risk Management Operations | Karen L. Moss | 301-796-5530 |
| Deputy Director | Joanna Weitershausen | 301-796-5530 |
| Field Programs Branch | Allen Wynn | 301-796-5530 |
| Regulatory Policy and Systems Branch | Theresa McDonald | 301-796-5530 |
| Recall Branch | Rita Hoffman | 301-796-5530 |
| Division of Bioresearch Monitoring | Michael Marcarelli | 301-796-5490 |
| Program Enforcement Branch A | Linda Godfrey | 301-796-5490 |
| Program Enforcement Branch B | Levering Keely | 301-796-5490 |
| Special Investigations Branch | Anne Hawthorn (acting) | 301-796-5490 |
| Division of Enforcement A | Betty W. Collins | 301-796-5770 |
| Deputy Director | George Kroehling | 301-796-5770 |
| Dental, ENT and Ophthalmic Devices Branch | Ronald L. Swann | 301-796-5770 |
| OB/GYN, Gastro. & Urology Devices Branch | Paul Tilton | 301-796-5770 |
| General Hospital Devices Branch | Valerie Flournoy | 301-796-5770 |
| General Surgery Devices Branch | Thomas Knott | 301-796-5770 |
| Division of Enforcement B | Gladys Rodriguez | 301-796-5540 |
| Deputy Director | Stacie Bilek (acting) | 301-796-5540 |
| Cardiac Rhythm and Electophysiology Devices Branch | Michelle Noonan-Smith (acting) | 301-796-5540 |
| Orthopedics and Physical Medicine & Anesthesiology Devices Branch | Matthew Krueger (acting) | 301-796-5540 |
| Radiology, Anesthesiology & Neurology Devices Branch | Jennifer Medicus | 301-796-5540 |
| Vascular & Circulatory Support Devices Branch | Dorothy Lee | 301-796-5540 |
| Office of Device Evaluation | ||
| Director: | Donna Bea Tillman, Ph.D. | 301-796-5550 |
| Deputy Director for Clinical | Markham Luke, M.D. | 301-796-5550 |
| Deputy Director for Engineering and Science Review | Christy Foreman | 301-796-5550 |
| Deputy Director for Premarket Program Management | Barbara Zimmerman | 301-796-5550 |
| Advisory Panel Coordinator | Geretta Wood | 301-796-5550 |
| Program Management Office | Kathryn K. Appler | 301-796-5560 |
| Deputy Director | Sharyn (Lesa) A. Dowtin | 301-796-5560 |
| Program Operations Staff | Robert Gatling | 301-796-6560 |
| Premarket Approval Section | Nicole Wolanski | 301-796-6570 |
| Investigational Device Exemption Section | Stephen P. Rhodes | 301-796-6564 |
| Premarket Notification (510(k)) Section | Heather Rosecrans | 301-796-6571 |
| Division of Surgical, Orthopedic, and Restorative Devices | Mark Melkerson | 301-796-5650 |
| Deputy Director I | Barbara Buch, M.D. | 301-796-5650 |
| Deputy Director II | Peter Rumm, M.D. | 301-796-5650 |
| Plastic & Reconstructive Surgery Devices Branch | David Krause, Ph.D. | 301-796-6442 |
| General Surgery Devices Branch | Neil R. Ogden | 301-796-6397 |
| Orthopedic Joint Devices Branch | Jonette Foy, Ph.D. | 301-796-5630 |
| Orthopedic Spine Devices Branch | Ronald Jean, Ph.D. | 301-796-6920 |
| Restorative Devices Branch | Laurence Coyne | 301-796-5650 |
| Division of Cardiovascular Devices | Bram D. Zuckerman, M.D. | 301-796-7000 |
| Deputy Director I | Donna Lochner | 301-796-7000 |
| Deputy Director II | William MacFarland | 301-796-7000 |
| Pacing, Defibrillator and Leads Branch | Mitchell Shein | 301-796-5630 |
| Cardiac Electrophysiology & Monitoring Devices Branch | Elias Mallis | 301-796-5630 |
| Interventional Cardiology Devices Branch | Ashley Boam | 301-796-5570 |
| Circulatory Support and Prosthetic Devices Branch | Matthew Hillebrenner | 301-796-6940 |
| Peripheral Vascular Devices Branch | Kenneth Cavanaugh, Ph.D. | 301-796-6950 |
| Division of Ophthalmic, Neurological, and ENT Devices | Malvina Eydelman, M.D. | 301-796-5620 |
| Deputy Director | Kesia Alexander, Ph.D. | 301-796-5620 |
| Clinical Deputy Director | Eric Mann, M.D., Ph.D. | 301-796-5620 |
| Associate Director | Deborah Falls | 301-796-5620 |
| Neurodiagnostic and Neurotherapeutic Devices Branch | Quynh Hoang | 301-796-6610 |
| Intraocular, Cornea and Neuromaterials Implants Branch | Vacant Tina Kiang | 301-796-6860 |
| Ophthalmic Lasers, Neuromuscular Stimulators, and Diagnostics Branch | 301-796-6620 | |
| Ear, Nose, and Throat Devices Branch | Srinivas Nandkumar, Ph.D | 301-796-6890 |
| Division of Reproductive, Abdominal, and Radiological Devices | Janine Morris (acting) | 301-796-6650 |
| Clinical Deputy Director | Herbert Lerner, M.D. | 301-796-6650 |
| Scientific Deputy Director | Joyce Whang, Ph.D. | 301-796-6650 |
| Obstetrics/Gynecology Devices Branch | Colin M. Pollard | 301-796-6650 |
| Urology and Lithotripsy Devices Branch | Herbert Lerner, M.D. (acting) | 301-796-6630 |
| Gastroenterology and Renal Devices Branch | Carolyn Neuland, Ph.D. | 301-796-5590 |
| Radiological Devices Branch | Michael O'Hara , Ph.D., (acting) | 301-796-5790 |
| Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices | M. Susan Runner, D.D.S. (acting) | 301-796-5580 |
| Deputy Director | Anthony Watson (acting) | 301-796-5580 |
| Associate Director for Operations | Kwame Ulmer (acting) | 301-796-5580 |
| Anesthesiology and Respiratory Devices Branch | Lester Schultheis | 301-796-6292 |
| General Hospital Devices Branch | Anthony Watson | 301-796-6296 |
| Infection Control Devices Branch | Sheila Murphey, M.D. | 301-796-6302 |
| Dental Devices Branch | M. Susan Runner, D.D.S. | 301-796-6282 |
| Office of In Vitro Diagnostic Device Evaluation and Safety | ||
| Director: | Alberto Gutierrez, Ph.D. (Designee) | 301-796-5453 |
| Deputy Director, New Product Evaluation | Donald St. Pierre | 301-796-5454 |
| Deputy Director, Patient Safety and Product Quality | James L. Woods | 301-796-6225 |
| Associate Director for Policy and Operations | Vacant | |
| Chief Medical Officer | Robert L. Becker, Jr., M.D. | 301-796-5450 |
| Director, Personalized Medicine Staff | Elizabeth A. Mansfield, Ph.D. | 301-796-4664 |
| Associate Director for Clinical Studies | Marina V. Kondratovich, Ph.D. | 301-796-6036 |
| Associate Director for Science and Technology | Zivana Tezak-Fragale, Ph.D. | 301-796-6206 |
| Associate Director for Surveillance and Outreach Programs | Jean M. Cooper, D.V.M. | 301-796-5672 |
| Scientific Policy Advisor | Vacant | |
| Program Management Officer | David R. Warren | 301-796-6223 |
| Division of Chemistry and Toxicology Devices | Courtney C. Harper, Ph.D. | 301-796-5458 |
| Associate Director for Chemistry | Carol C. Benson | 301-796-5459 |
| Associate Director for Toxicology | Lakshman Ramamurthy, Ph.D., (acting) | 301-796-6154 |
| Division of Immunology and Hematology Devices | Maria M. Chan, Ph.D. | 301-796-5482 |
| Associate Director for Immunology | Reena Philip, Ph.D. | 301-796-6179 |
| Associate Director for Hematology | Leonthena Carrington | 301-796-6164 |
| Division of Microbiology Devices | Sally A. Hojvat, Ph.D. | 301-796-5455 |
| Associate Director for Bacteriology | Freddie M. Poole | 301-796-5457 |
| Associate Director for Virology | Uwe Scherf, Ph.D. | 301-796-5456 |
| Office of Surveillance and Biometrics | ||
| Director: | Susan N. Gardner, Ph.D. | 301-796-5996 |
| Deputy Director | Stephen M. Sykes | 301-796-6005 |
| Deputy Director | Thomas P. Gross, M.D. | 301-796-5997 |
| Issues Management Staff | Vacant | |
| Program Management Staff | Donna Schwartz | 301-796-6004 |
| Division of Patient Safety Partnerships | Marilyn Flack | 301-796-6118 |
| Division of Epidemiology | Danica Marinac-Dabic, Ph.D., M.D. | 301-796-6689 |
| Epidemiology Evaluation and Research I | Ellen Pinnow | 301-796-6066 |
| Epidemiology Evaluation and Research II | Nilsa Loyo-Berrios | 301-796-6065 |
| Division of Postmarket Surveillance | Dave Buckles | 301-796-6052 |
| Deputy Director | Steven Chasin, Ph.D. | 301-796-6053 |
| Product Evaluation Branch I | Greg O'Connell | 301-796-6075 |
| Product Evaluation Branch II | Doug Wood | 301-796-6085 |
| Information Analysis Branch | Julie (Brandi) Stuart, (acting) | 301-796-6573 |
| Reporting Systems Monitoring Branch | Sharon Kapsch | 301-796-6104 |
| Division of Biostatistics | Greg Campbell, Ph.D. | 301-796-5750 |
| Deputy Director | Gerry Gray | 301-796-6012 |
| Deputy Director | Lilly Yue | 301-796-6033 |
| Cardiovascular and Ophthalmic Devices Branch | Chul Ahn (acting) | 301-796-6033 |
| Diagnostic Devices Branch | Lakshmi Vishnuvajjala | 301-796-6042 |
| General Surgical Devices Branch | Telba Irony | 301-796-6044 |
| Office of Science and Engineering Laboratories | ||
| Director: | Steven Pollack, Ph.D. | 301-796-2530 |
| Deputy Director for Science and Strategic Initiatives | William A. Herman | 301-796-2549 |
| Deputy Director for Program Policy and Evaluation | Subhas Malghan, Ph.D. | 301-796-2548 |
| Director, Standards Management Staff | Carol Herman | 301-796-6576 |
| 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 | Vacant | |
| Division of Physics | Joel Myklebust, P.E., Ph.D. | 301-796-2491 |
| Deputy Director | Brian Beard, Ph.D. | 301-796-2469 |
| Deputy Director | Isaac Chang, Ph.D. | 301-796-2789 |
| Division of Solid and Fluid Mechanics | Laurence W. Grossman, Ph.D. | 301-796-2530 |
| Deputy Director | Jon Casamento | 301-796-2499 |
| Division of Chemistry and Materials Science | Dinesh Patwardhan, Ph.D. (acting) | 301-796-2622 |
| Deputy Director | Vacant | |
| Division of Imaging and Applied Mathematics | Kyle Myers, Ph.D. | 301-796-2533 |
| 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 | 301-796-5660 |
| Deputy Director for Technical and Radiological Initiatives | John L. McCrohan | 301-796-5719 |
| Deputy Director for Communication and Education | Heather D. Howell | 301-796-5718 |
| Associate Director for Outreach and Review | Mark H. Barnett | 240-276-3970 |
| Assistant Director for Program Operations | Clifford D. Evans | 301-796-6644 |
| Special Assistant to the Director | Sharon M. Davis | 301-796-5717 |
| Staff College Director | Jacqueline Woodard | 301-796-5670 |
| Deputy Director | Laura Stewart | 301-796-5673 |
| Regulations Staff Director | Nancy Pirt (acting) | 301-796-6248 |
| Division of Health Communication | Jay A. Rachlin | 301-796-5722 |
| Deputy Director | Vacant | 301-796-5720 |
| Associate Director | Alvin W. Thomas | 301-796-5758 |
| Risk Communication Branch | Kristine B. Mejia | 301-796-5843 |
| Web Communication Branch | Laurel S. Mendelson | 301-796-5764 |
| Division of Small Manufacturers, International and Consumer Assistance | John F. Stigi | 301-796-5848 |
| Deputy Director | William Sutton | 301-796-5849 |
| Technical Assistance Branch | Joseph V. Tartal | 301-796-5853 |
| Regulatory Assistance Branch | Yung Pak | 301-796-5856 |
| International Relations and External Affairs Staff | Carole C. Carey | 301-796-5708 |
| Division of Communication Media | Chad Heupel | 301-796-0922 |
| Television Design and Development Branch | Vacant | |
| Division of Mammography Quality and Radiation Programs | Helen J. Barr, M.D. | 301-796-5713 |
| Deputy Director | Thomas R. Ohlhaber | 301-796-5712 |
| Associate Director for Policy and Clinical Affairs | Charles A. Finder, M.D. | 301-796-5715 |
| Associate Director for Administration | Kathleen M. Sheridan | 301-796-5714 |
| Accreditation and Certification Branch | Kathleen A. Franke | 301-796-5710 |
| Radiation Programs Branch | Petro Shandruk | 301-796-5889 |
| Information Management Branch | Timothy J. Haran | 301-796-6625 |
| Inspection and Compliance Branch | Vacant | 301-796-5911 |
| Diagnostic Devices Branch | Sean M. Boyd | 301-796-5895 |
| Electronic Products Branch | Robert Doyle | 301-796-5863 |
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