| Immediate Office |
| Office Director |
William Maisel, M.D. |
301-796-5550 |
| Principal Deputy Office Director |
Owen Faris, Ph.D. |
301-796-6356 |
| Deputy Office Director for Operations |
Daniel Montgomery |
301-796-5987 |
| Deputy Director for Regulatory Policy |
Angela Krueger |
301-796-5550 |
| Associate Director for Operations |
Debra Grygier (Acting) |
301-796-5934 |
| Quality and Analytics Staff |
| Associate Director |
Cherron Blakely, DBA |
301-796-6835 |
| Clinical and Scientific Policy Staff |
| Associate Director and Chief Medical Science Officer |
Randall Brockman, M.D. |
301-796-5550 |
| Deputy Associate Director |
Michael Hoffman |
301-796-6476 |
| Supervisor for Clinical and Scientific Policy Staff Team 1 |
Vacant |
|
| Supervisor for Clinical and Scientific Policy Staff Team 2 |
Kimberly Brown Smith, M.D. (Acting) |
301-796-5539 |
| Strategic Initiatives Staff |
| Associate Director |
Ellen Olson, Ph.D. (Acting) |
301-796-4322 |
| Regulation, Policy and Guidance Staff |
| Associate Director |
Rebecca Nipper |
301-796-6527 |
| Regulatory, Policy and Combination Products Staff |
| Associate Director |
James Bertram |
301-796-9588 |
| Compliance and Quality Staff |
| Associate Director |
Erin Keith |
301-796-6384 |
| Post Market Programs Staff |
| Associate Director |
Aron Yustein, M.D. |
301-796-6006 |
| Professional Development Staff |
| Associate Director |
Dawn White |
240-402-3184 |
| Communications Staff |
| Associate Director |
Anne Hawthorn, J.D. |
301-796-6561 |
| Operations Staff |
|
| Associate Director |
Lesa Dowtin |
301-796-5560 |
| Assistant Director |
Casey Stewart |
240-402-5046 |
| Office of Regulatory Programs |
| Office Director |
RADM Sean Boyd |
301-796-5895 |
| Deputy Office Director |
Barbara Zimmerman |
301-796-5560 |
| Deputy Office Director |
Michael Ryan |
301-796-6283 |
| Chief Medical Officer |
Vacant |
|
| Associate Director for Operations |
Kendra Brooks |
240-402-2977 |
| Associate Director for Professional Development |
Steven Chasin, Ph.D. |
301-796-6053 |
| Regulatory Systems and Data Management Staff |
| Associate Director |
Lisa Lim, Ph.D. |
301-796-6443 |
| Division of Regulatory Programs 1 (Submission Support) |
| Division Director |
Joshua Nipper |
301-796-5640 |
| Deputy Division Director |
Geeta Pamidimukkala (Acting) |
301-796-6453 |
| Assistant Director for 510(k), DeNovo, 513(g), Device Determinations and Custom Devices Lifecycle Team |
Marjorie Shulman |
301-796-5640 |
| Assistant Director for PMA, HDE, Presubmission and Device Tracking Lifecycle Team |
Dharmesh Patel |
301-796-3289 |
| Division of Regulatory Programs 2 (Establishment Support) |
| Division Director |
CDR Cesar Perez |
301-796-5476 |
| Deputy Division Director |
Dorothy Lee |
301-796-5687 |
| Assistant Director for Imports and Registration and Listing Team |
Deniz Mackey |
301-796-5908 |
| Assistant Director for Exports Team |
Leila M. Lawrence |
240-402-4020 |
| Assistant Director for FDA Inspections and Regulatory Audits Team |
CDR Neil Mafnas |
240-402-4020 |
| Assistant Director for Quality Systems Team |
Vacant |
|
| Division of Regulatory Programs 3 (Market Intelligence) |
| Division Director |
Donna Engleman |
301-796-5530 |
| Deputy Division Director |
Vacant |
|
| Assistant Director for Recalls and Shortages Team |
James N.Walker |
301-796-5910 |
| Assistant Director for Allegations Team |
Paola Barnett |
301-796-5462 |
| Assistant Director for MDR Team |
Michelle Rios |
301-796-6107 |
| Assistant Director for Lifecycle Program Analytics Team |
Vacant |
|
| Office of Clinical Evidence and Analysis |
| Office Director |
Daniel Canos, Ph.D. |
301-796-9578 |
| Deputy Office Director |
Felipe Aguel, Ph.D. |
301-837-7631 |
| Deputy Office Director |
Jill Marion |
301-796-6128 |
| Associate Director for Regulatory Research, Evidence Generation and Analysis |
Jose (Pablo) Morales, M.D. |
301-796-6378 |
| Associate Director |
Danica Marinac-Dabic, M.D., Ph.D. |
301-796-6689 |
| Associate Director for Operations |
Nicole Jones |
301-796-6062 |
| Associate Director for Professional Development |
Vacant |
|
| Division of Clinical Evidence and Analysis 1 (Clinical Science and Quality) |
| Division Director |
Soma Kalb, Ph.D. |
301-796-5490 |
| Deputy Division Director |
Adam Donat |
301-796-5490 |
| Deputy Division Director |
Nilsa Loyo-Berrios, Ph.D. |
301-796-6065 |
| Deputy Division Director |
Hina Pinto (Acting) |
301-796-6351 |
| Assistant Director Policy and Operations Team 1 |
Maureen Dreher, Ph.D. |
301-796-2505 |
| Assistant Director for Clinical Evidence Quality 1 Team 2 |
Veronica Calvin |
301-796-5490 |
| Assistant Director for Clinical Evidence Quality 2 Team 3 |
Sheena Green |
301-796-5490 |
| Assistant Director for Methods, Analysis and Infrastructure 1 Team 4 |
Dongyi (Tony) Du, M.D., Ph.D. |
240-402-4241 |
| Assistant Director for Methods, Analysis and Infrastructure 2 Team 5 |
Jiping Chen, M.D., Ph.D. |
301-796-6058 |
| Assistant Director for Outreach and Partnerships 1 Team 6 |
Angela Mariani |
301-796-2233 |
| Assistant Director for Outreach and Partnerships 2 Team 7 |
Julie Morabito, Ph.D. |
240-402-3839 |
| Assistant Director for Clinical Evidence Outcomes Research Team 8 |
Jacqueline Puigbo |
240-402-0342 |
| Division of Clinical Evidence and Analysis 2 (Biostatistics) |
| Division Director |
Yun-Ling Xu, Ph.D. (Acting) |
301-796-6031 |
| Deputy Division Director |
Yun-Ling Xu, Ph.D. |
301-796-6031 |
| Deputy Division Director |
Lilly Yue, Ph.D. |
301-796-6033 |
| Deputy Division Director |
Jason Beach |
301-518-5261 |
| Assistant Director for Biostatistics Team 1 |
Xu Yan |
301-796-6032 |
| Assistant Director for Biostatistics Team 2 |
Chul Ahn |
301-796-6026 |
| Assistant Director for Biostatistics Team 3 |
Hong (Laura) Lu, Ph.D. |
301-796-1699 |
| Assistant Director for Biostatistics Team 4 |
Rajesh Nair |
301-796-6021 |
| Assistant Director for Biostatistics Team 5 |
Bipasa Biswas |
301-796-5740 |
| Assistant Director for Biostatistics Team 6 |
Vandana Bhatia, Ph.D. |
301-796-6020 |
| Assistant Director for Biostatistics Team 7 |
Jianxiong Chu, Ph.D. |
301-796-6007 |
| Office of Health Technology 1 (OHT 1: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices) |
| Office Director |
Malvina Eydelman, M.D. |
301-796-5620 |
| Deputy Office Director |
Kesia Alexander, Ph.D. |
301-796-5620 |
| Deputy Office Director |
Denise Hampton, Ph.D. (Acting) |
301-796-6860 |
| Chief Medical Officer |
Eric Mann, M.D. |
301-796-5620 |
| Associate Director |
Nilsa Loyo-Berrios, Ph.D. (Acting) |
301-796-6065 |
| Associate Director |
CDR Bradley Cunningham |
301-796-6484 |
| Associate Director for Operations |
Maritze Ortega |
301-796-5625 |
| Associate Director for Professional Development |
Vacant |
|
| Safety Signal Manager |
Allison O'Neil |
301-796-4141 |
| Division of Health Technology 1 A (Ophthalmic Devices) |
| Division Director |
Tieuvi Nguyen, Ph.D. |
301-796-7018 |
| Assistant Director for Intraocular Lens and Accessory Devices |
Bennett Walker |
301-796-5093 |
| Assistant Director for Contact Lenses and Dry Eye Devices |
Angelo Green, Ph.D. |
301-796-6828 |
| Assistant Director for Retinal and Diagnostic Devices |
Elvin Ng |
301-796-6484 |
| Assistant Director for Glaucoma, Cornea, and Surgical Devices |
LT Charles Chiang |
301-796-6459 |
| Division of Health Technology 1 B (Dental and ENT Devices) |
| Division Director |
Srinivas Nandkumar, Ph.D. |
301-796-6480 |
| Assistant Director for Implantable Dental Devices |
Andrew Steen |
301-796-6284 |
| Assistant Director for Restorative and Surgical Dental Devices |
Michael Adjodha |
301-796-6276 |
| Assistant Director for ENT Devices |
Shu-Chen Peng, Ph.D. |
301-796-6481 |
| Division of Health Technology 1 C (Anesthesia, Respiratory, and Sleep Devices) |
| Division Director |
Vacant |
|
| Assistant Director for Anesthesia Devices |
Todd Courtney |
301-796-5580 |
| Assistant Director for Respiratory Devices |
James J. Lee, Ph.D. |
301-796-8463 |
| Assistant Director for Sleep Disordered Breathing Devices |
Rachana Visaria |
240-402-5628 |
| Office of Health Technology 2 (OHT 2: Cardiovascular Devices) |
| Office Director |
Bram Zuckerman, M.D. |
301-796-6315 |
| Deputy Office Director |
Matthew Hillebrenner |
301-796-7000 |
| Deputy Office Director |
William MacFarland |
301-796-5547 |
| Deputy Office Director |
Kenneth Cavanaugh, Ph.D. |
301-796-6377 |
| Chief Medical Officer |
Andrew Farb, M.D. |
301-796-6343 |
| Associate Director |
Vacant |
|
| Associate Director for Operations |
Vacant |
|
| Associate Director Professional Development |
Vacant |
|
| Safety Signal Manager |
Megan Gatski |
301-796-0342 |
| Division of Health Technology 2 A (Cardiac Electrophysiology, Diagnostics, and Monitoring Devices) |
| Division Director |
Jessica Paulsen |
301-796-6883 |
| Assistant Director for Blood Pressure and Flow Devices |
LT Stephen Browning |
301-796-5540 |
| Assistant Director for Cardiac Ablation, Mapping, and Imaging Devices |
Vacant |
|
| Assistant Director for External Heart Rhythm and Rate Devices |
Jennifer Shih Kozen |
301-796-5813 |
| Assistant Director for Implantable Electrophysiology Devices |
Hetal Odobasic |
204-402-6540 |
| Division of Health Technology 2 B (Circulatory Support, Structural and Vascular Devices) |
| Division Director |
Nicole Ibrahim, Ph.D. |
301-796-7000 |
| Assistant Director for Cardiac Occluders and Hemostasis Devices |
Rachel Neubrander, Ph.D. |
301-796-6940 |
| Assistant Director for Circulatory Support Devices |
Fernando Aguel |
301-796-7000 |
| Assistant Director for Heart Valve Devices |
Jaime Raben |
301-796-1137 |
| Assistant Director for Vascular and Endovascular Devices |
Carmen Gacchina Johnson, Ph.D. |
240-402-5244 |
| Division of Health Technology 2 C (Coronary and Peripheral Intervention Devices) |
| Division Director |
Brian Pullin |
301-796-6455 |
| Assistant Director for Coronary Interventional Devices |
Lydia Glaw, Ph.D. |
301-796-1456 |
| Assistant Director for Peripheral Interventional Devices |
Misti Malone, Ph.D. |
301-796-2520 |
| Assistant Director for Plaque Modification Devices |
Gregory O'Connell |
301-796-6075 |
| Office of Health Technology 3 (OHT 3: Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors) |
| Office Director |
Courtney Lias, Ph.D. (Acting) |
301-796-5458 |
| Deputy Office Director |
Joyce Whang, Ph.D. |
301-796-7030 |
| Deputy Office Director |
Charles Viviano, M.D., Ph.D. |
240-402-2975 |
| Associate Director |
Ann Ferriter |
301-796-5686 |
| Associate Director for Operations |
Christine Lee |
301-796-7030 |
| Associate Director for Professional Development |
Vacant |
|
| Safety Signal Manager |
Kathleen White |
301-796-5832 |
| Division of Health Technology 3 A (Gastroenterology, Renal, Endoscopy, Transplant and Obesity Devices) |
| Division Director |
Glenn Bell, Ph.D. |
301-796-7030 |
| Assistant Director for Renal and Transplantation Devices |
Carolyn Neuland, Ph.D. |
301-796-7030 |
| Assistant Director for Gastroenterology and Endoscopy Devices |
Shanil Haugen |
301-796-0301 |
| Assistant Director for Obesity and Hepatobiliary Devices |
Thelma Valdes (Acting) |
301-796-9621 |
| Division of Health Technology 3 B (Reproductive and Urology Devices) |
| Division Director |
Sharon Andrews |
301-796-6529 |
| Assistant Director for Obstetrical and Reproductive Health Devices |
Monica Garcia |
240-402-2791 |
| Assistant Director for Gynecological and Surgical Devices |
Jason Roberts |
240-402-6400 |
| Assistant Director for Urological Devices |
Mark Antonino (Acting) |
240-402-9980 |
| Assistant Director for Incontinence and Female Urological Devices |
Vacant |
|
| Division of Health Technology 3 C (Drug Delivery and General Hospital Devices and Human Factors) |
| Division Director |
CAPT Alan Stevens (Acting) |
301-796-5580 |
| Assistant Director for Injection Devices |
Rumi Young (Acting) |
301-796-6005 |
| Assistant Director for Infusion Devices |
Marc Neubauer (Acting) |
301-796-6526 |
| Assistant Director for General Hospital Devices |
Payal Patel (Acting) |
240-402-6029 |
| Assistant Director for Human Factors and Reliability Engineering |
Rita Lin (Acting) |
| Office of Health Technology 4 (OHT 4: Surgical and Infection Control Devices) |
| Office Director |
Binita Ashar, M.D. |
301-796-6970 |
| Deputy Office Director |
David Krause, Ph.D. |
301-796-6970 |
| Deputy Office Director |
CDR Jennifer Stevenson |
301-769-6970 |
| Chief Medical Science Officer |
Dorian Korz, M.D. |
301-796-4335 |
| Associate Director for Operations |
Germarie Sanchez-Pomales |
301-796-4573 |
| Associate Director for Professional Development |
Melissa Eakle |
301-796-5530 |
| Safety Signal Manager |
Karen Nast |
301-796-6864 |
| Division of Health Technology 4 A (General Surgery Devices) |
| Director |
Vacant |
|
| Assistant Director for Robotic Assisted Surgery Devices |
Je An, Ph.D. |
240-402-0018 |
| Assistant Director for Non-Light Based Energy Devices |
Long Chen, Ph.D. |
301-796-6970 |
| Assistant Director for Light Based Energy Devices |
Purva Pandya |
240-402-9979 |
| Assistant Director for Cancer Diagnosis and Treatment Devices |
Neil Ogden |
301-796-6970 |
| Division of Health Technology 4 B (Infection Control and Plastic and Reconstructive Surgery) |
| Division Director |
Cynthia Chang, Ph.D. |
301-796-6891 |
| Assistant Director for Sterility Devices |
Vacant |
|
| Assistant Director for Personal Protective Equipment, Reprocessing and Disinfection Devices |
CAPT Elizabeth Claverie |
301-796-6298 |
| Assistant Director for Plastic Surgery Implant Devices |
Cindy Chowdhury |
240-402-6647 |
| Assistant Director for Plastic Surgery Skin and Wound Devices |
Vacant |
|
| Office of Health Technology 5 (OHT 5: Neurological and Physical Medicine Devices) |
| Office Director |
Christopher Loftus, M.D. (Acting) |
301-796-4377 |
| Deputy Office Director |
John Marler, M.D. |
301-796-4221 |
| Deputy Office Director |
CAPT Nina Mezu-Nwaba |
301-796-5494 |
| Chief Medical Officer |
Christopher Loftus, M.D. |
301-796-4377 |
| Associate Director |
Vacant |
|
| Associate Director for Operations |
Tonja Galberth |
301-796-5959 |
| Associate Director for Professional Development |
Vacant |
|
| Safety Signal Manager |
Sonja Sokic |
240-402-3679 |
| Division of Health Technology 5 A (Neurosurgical, Neurointerventional and Neurodiagnostic) |
| Division Director |
Xiaolin Zheng, Ph.D. |
301-796-2823 |
| Assistant Director for Neurosurgical Devices |
Adam Pierce |
240-402-6128 |
| Assistant Director for Neurointerventional Devices |
Naira Muradyan |
240-402-4098 |
| Assistant Director for Neurodiagnostic Devices |
Jay Gupta |
301-796-2795 |
| Division of Health Technology 5 B (Neuromodulation and Rehabilitation Devices) |
| Division Director |
Vivek Pinto, Ph.D. |
301-796-6610 |
| Assistant Director for Neurostimulation-Neurology Devices |
Vacant |
|
| Assistant Director for Neuromodulation-Psychiatry Devices |
Pamela Scott |
301-796-5433 |
| Assistant Director for Acute Injury Devices |
Heather Dean |
240-402-9874 |
| Assistant Director for Neurodegenerative Devices |
Amber Ballard, Ph.D. |
240-402-9983 |
| Office of Health Technology 6 (OHT 6: Orthopedic Devices) |
| Office Director |
CAPT Raquel Peat |
301-796-5650 |
| Deputy Office Director |
Mark Melkerson |
301-796-5650 |
| Deputy Office Director |
Vacant |
|
| Chief Medical Officer |
Vincent Devlin, M.D. |
301-796-6414 |
| Associate Director for Operations |
CAPT Tania Schuppius |
301-796-6446 |
| Associate Director for Professional Development |
Vacant |
|
| Safety Signal Manager |
Hongying (Helen) Jiang, Ph.D. |
301-796-6087 |
| Division of Health Technology 6 A (Joint Arthroplasty Devices) |
| Division Director |
William Jung |
301-796-6228 |
| Assistant Director for Knee Arthroplasty Devices |
Ting Song |
301-796-7667 |
| Assistant Director for Hip Arthroplasty Devices |
Vesa Vuniqi |
301-796-6439 |
| Assistant Director for Shoulder Arthroplasty Devices |
Michael Owens |
301-796-6411 |
| Division of Health Technology 6 B (Spinal Devices) |
|
|
| Division Director |
Ronald Jean, Ph.D. |
301-796-5650 |
| Assistant Director Intracolumnar Spinal Devices |
Brent Showalter, Ph.D. |
240-402-1840 |
| Assistant Director Extracolumnar Spinal Devices |
Colin O'Neil |
301-796-6428 |
| Division of Health Technology 6 C (Restorative, Repair and Trauma Devices) |
| Division Director |
Laurence Coyne, Ph.D. |
301-796-5650 |
| Assistant Director for Restorative, Repair, Trauma and Fracture Fixation Devices |
Laura Rose |
301-348-1947 |
| Assistant Director for Stereotaxic, Bone Growth Simulators and Fracture Fixation Device |
Shumaya Ali |
301-796-2356 |
| Office of Health Technology 7 (OHT 7: In Vitro Diagnostics and Radiological Health - OIR) |
| Office Director |
Timothy Stenzel, M.D., Ph.D. |
301-796-9523 |
| Deputy Office Director for New Product Evaluation |
Donald St. Pierre |
301-796-5454 |
| Deputy Office Director for Patient Safety and Product Quality |
Courtney Lias, Ph.D. |
301-796-5458 |
| Deputy Office Director for Radiological Health |
Robert Ochs, Ph.D. |
301-796-6661 |
| Deputy Office Director for Personalized Medicine |
Wendy Rubinstein, M.D., Ph.D. |
240-402-7070 |
| Associate Director for Strategic Initiatives |
Vacant |
|
|
Associate Director for Regulatory Programs
|
Toby Lowe |
301-796-6512 |
| Associate Director for Regulatory Counsel |
Scott T. McFarland, J.D. |
301-796-6217 |
| Associate Director for Medical Affairs |
Sara Brenner, M.D. |
240-402-7533 |
| Chief Medical Officer for Radiological Health |
Donald Miller, M.D. |
301-796-3299 |
| Associate Director for Professional Development |
Vacant |
|
| Associate Director for Operations |
Michelle Sutter, Ed.D. |
301-796-7259 |
| Division of Program Operations and Management |
| Division Director |
Robert A. Sauer |
301-796-3580 |
| Deputy Division Director |
Vacant |
|
| Branch Chief for Laboratory Improvements, Outreach and Analysis |
Andrew Grove, Ph.D. |
301-796-6198 |
| Branch Chief for Third Party 510(k) Program |
Gregory Pishko |
240-402-6635 |
| Division of Chemistry and Toxicology Devices |
| Division Director |
Kellie Kelm, Ph.D. |
301-796-6145 |
| Deputy Division Director |
Marianela Perez-Torres, Ph.D. |
301-796-1489 |
| Branch Chief for Chemistry |
Juliane Lessard, Ph.D. (Acting) |
240-402-6126 |
| Branch Chief for Diabetes |
Leslie Landree (Acting) |
301-796-6147 |
| Branch Chief for Toxicology |
James Mullally, Ph.D. |
240-402-5021 |
| Branch Chief for Cardio-Renal Diagnostics |
Paula Caposino, Ph.D. |
301-796-6160 |
| Division of Immunology and Hematology Devices |
| Division Director |
Lea R. Carrington |
301-796-6164 |
| Deputy Division Director |
Takeesha Taylor-Bell |
240-402-6566 |
| Branch Chief for Hematology |
Vacant |
240-402-6566 |
| Branch Chief for Immunology and Flow Cytometry |
Ying Mao |
301-796-6635 |
| Division of Molecular Genetics and Pathology |
| Division Director |
Reena Philip, Ph.D. |
301-796-6179 |
| Deputy Division Director |
Donna Roscoe, Ph.D. |
301-796-6183 |
| Branch Chief for Molecular Pathology and Cytology |
Soma Gosh, Ph.D. |
301-796-5333 |
| Branch Chief for Molecular Genetics |
Zivana Tezak (Acting) |
301-796-6206 |
| Division of Microbiology Devices |
| Director |
Uwe Scherf, Ph.D. |
301-796-5456 |
| Deputy Director |
Vacant |
|
| Branch Chief for Viral Respiratory and HPV |
Himani Bisht (Acting) |
301-796-6189 |
| Branch Chief for General Viral and Hepatitis |
Maria Garcia, Ph.D. |
301-796-7017 |
| Branch Chief for General Bacterial and Antimicrobial Susceptibility |
Ribhi Shawar, Ph.D. |
301-796-6698 |
| Branch Chief for Bacterial Respiratory and Medical Countermeasures |
Kristian Roth, Ph.D. |
301-796-7024 |
| Division of Radiological Health |
| Division Director |
Thalia T. Mills, Ph.D. |
301-796-6641 |
| Deputy Division Director |
Michael O'Hara, Ph.D. |
301-796-0294 |
| Deputy Division Director |
LCDR David Dar (Acting) |
301-796-5617 |
| Branch Chief for Magnetic Resonance and Electronic Products |
CAPT Patrick Hintz |
301-796-6927 |
| Branch Chief for Diagnostic X-Ray Systems |
Laurel Burk |
301-796-5933 |
| Branch Chief for Nuclear Medicine and Radiation Therapy |
Julie Sullivan(Acting) |
240-402-4973 |
| Branch Chief for Mammography, Ultrasound and Imaging Software |
Jessica Lamb |
301-796-6167 |
| Division of Mammography Quality Standards |
| Division Director |
David Lee, M.D. |
301-796-4120 |
| Deputy Division Director |
Preetham Sudhaker |
301-796-5911 |
| Branch Chief for Program Management |
Normica Facey |
301-796-5914 |
| Branch Chief for Information Management |
Dennis L. Trammell |
301-796-5926 |