| Immediate Office |
| Office Director |
Owen Faris, Ph.D. (Acting) |
301-796-6356 |
| Principal Deputy Office Director |
Michael Hoffman (Acting) |
301-796-6610 |
| Deputy Office Director for Operations |
Daniel Montgomery |
301-796-5987 |
| Deputy Director for Regulatory Policy |
Angela Krueger |
301-796-5550 |
| Associate Director for Total Product Life Cycle Review Program Innovation |
Matthew Hillebrenner |
301-796-6358 |
| 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 |
301-796-6610 |
| Supervisor for Clinical and Scientific Policy Staff 1 |
Vacant |
|
| Supervisor for Clinical and Scientific Policy Staff 2 |
Jacqueline Cunkelman, M.D. |
240-402-7771 |
| Strategic Initiatives Staff |
| Associate Director |
Ellen Olson, Ph.D. |
301-796-4322 |
| Regulation, Policy and Guidance Staff |
| Associate Director |
Rebecca Nipper |
301-796-6527 |
| Regulatory, Policy and Combination Products |
| Associate Director |
Hina Pinto |
301-796-6351 |
| Compliance and Quality |
| Associate Director |
Keisha Thomas |
301-796-5479 |
| Supervisory for Compliance and Quality 1 |
Vacant |
|
| Supervisory for Compliance and Quality 2 |
Keisha Thomas |
301-796-5479 |
| Post Market Programs |
| Associate Director |
Martha Betz, Ph.D. |
301-796-2844 |
| Professional Development |
| Associate Director |
Dawn White |
240-402-3184 |
| Communications |
| Associate Director |
Anne Hawthorn, J.D. |
301-796-6561 |
| Operations Staff |
| Associate Director |
Pamela Stanziani |
N/A |
| Assistant Director |
Vacant |
|
| OPEQ Digital Health |
| Associate Director |
Jessica Paulsen |
301-796-6883 |
| Office of Regulatory Programs |
| Office Director |
RDML Sean Boyd |
301-796-5895 |
| Deputy Office Director |
Barbara Zimmerman |
301-796-5560 |
| Deputy Office Director |
Michael Ryan |
301-796-6283 |
| Division of Regulatory Programs 1 (Submission Support) |
| Division Director |
Joshua Nipper |
301-796-5640 |
| Deputy Division Director |
Mary Wen |
240-402-4913 |
| Assistant Director for 510(k), DeNovo, 513(g), Device Determinations and Custom Devices Lifecycle |
Angela DeMarco |
301-796-4471 |
| Assistant Director for PMA, HDE, Pre-submission and Device Tracking Lifecycle |
Susannah Gilbert |
301-796-7633 |
| 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 |
Deniz Mackey |
301-796-5908 |
| Assistant Director for Exports |
Leila M. Lawrence |
240-402-4020 |
| Assistant Director for FDA Inspections and Regulatory Audits |
LCDR Kenneth Chen |
301-796-5595 |
| Division of Regulatory Programs 3 (Surveillance Support) |
| Division Director |
Donna Engleman |
301-796-6117 |
| Deputy Division Director |
Indira Konduri |
301-796-6658 |
| Assistant Director for Recalls and Shortages |
James "Nick" Walker |
301-796-5910 |
| Assistant Director for Allegations |
Paola Barnett |
301-796-5462 |
| Assistant Director for MDR |
Michelle Rios |
301-796-6107 |
| Division of Regulatory Programs 4 (Regulatory Systems, Tools, and Data Management) |
| Division Director |
Lisa Lim, Ph.D. |
301-796-6443 |
| Deputy Division Director |
Vacant |
|
| Assistant Director for Regulatory Systems Management |
Shawn Mcdonald |
N/A |
| Assistant Director for Tools and Templates |
Patrick Axtell |
301-796-6462 |
| Assistant Director for Review Performance Analytics |
Alyson James |
N/A |
| Assistant Director for Market Intelligence Analytics |
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 |
Danica Marinac-Dabic, M.D., Ph.D. |
301-796-6689 |
| Division of Clinical Evidence and Analysis 1 (Clinical Science and Quality) |
| Division Director |
Soma Kalb, Ph.D. |
301-796-5490 |
| Deputy Division Director |
Vacant |
|
| Deputy Division Director |
Vacant |
|
| Assistant Director for Policy and Operations 1 |
Ouided Rouabhi |
240-402-2672 |
| Assistant Director for Policy and Operations 2 |
Jayna Wiebel |
301-796-2593 |
| Assistant Director for Clinical Evidence Quality 1 |
Albert Rodriquez |
301-796-6336 |
| Assistant Director for Clinical Evidence Quality 2 |
Irfan Khan |
301-796-5659 |
| Division of Clinical Evidence and Analysis 2 (Biostatistics) |
| Division Director |
Gregory Alexander, Ph.D. |
N/A |
| Deputy Division Director |
Yun-Ling Xu, Ph.D. |
301-796-6031 |
| Deputy Division Director |
Ozan Aygun, Ph.D. |
N/A |
| Deputy Division Director |
Lilly Yue, Ph.D. |
301-796-6033 |
| Supervisor for Biostatistics Team 1 |
Xu "Sherry" Yan, Ph.D. |
301-796-6032 |
| Assistant Director for Biostatistics 2 |
Yu "Audrey" Zhao |
301-796-6165 |
| Supervisor for Biostatistics Team 3 |
Hong "Laura" Lu, Ph.D. |
301-796-1699 |
| Supervisor for Biostatistics Team 4 |
Rajesh Nair, Ph.D. |
301-796-6021 |
| Supervisor for Biostatistics Team 5 |
Bipasa Biswas, Ph.D. |
301-796-5740 |
| Assistant Director for Biostatistics 6 |
Nelson Lu |
301-796-6018 |
| Assistant Director for Biostatistics 7 |
Li Ming Dong |
240-402-6608 |
| Assistant Director for Biostatistics 8 |
Yu "Audrey" Zhao, Ph.D. |
301-796-6165 |
| Assistant Director for Biostatistics 9 |
Hong "Laura" Lu, Ph.D. |
301-796-1699 |
| Division of Clinical Evidence and Analysis 3 (Clinical Science Outreach) |
| Division Director |
Rebecca Torguson |
301-796-3244 |
| Deputy Division Director |
Katrina Jacobs |
N/A |
| Deputy Division Director |
Vacant |
|
| Assistant Director for Clinical Evidence Outcomes Research 1 |
Rebecca Ward |
301-796-5288 |
| Assistant Director for Clinical Evidence Outcomes Research 2 |
Ashley Stenzel, Ph.D. |
N/A |
| Assistant Director for Outreach and Partnerships |
Elizabeth Gonzalez (Acting) |
301-796-6826 |
| 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. |
301-796-6860 |
| 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, Ph.D. |
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 |
Claudine Krawczyk |
240-402-3709 |
| 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 |
James J. Lee, Ph.D. |
301-796-8463 |
| Deputy Division Director |
Ting Song |
301-796-7677 |
| Assistant Director for Anesthesia Devices |
Bradley Quinn |
301-796-5575 |
| Assistant Director for Respiratory Devices |
Ethan Nyberg |
240-402-5973 |
| Assistant Director for Sleep Disordered Breathing Devices |
Rachana Visaria, Ph.D. |
240-402-5628 |
| Office of Health Technology 2 (OHT 2: Cardiovascular Devices) |
| Office Director |
Bram Zuckerman, M.D. |
301-796-6315 |
| Deputy Office Director |
Nicole Ibrahim, Ph.D. |
301-796-7000 |
| Deputy Office Director |
William MacFarland |
301-796-5547 |
| Deputy Office Director |
Kenneth Cavanaugh, Ph.D. |
301-796-6377 |
| Division of Health Technology 2 A (Cardiac Electrophysiology, Diagnostics, and Monitoring Devices) |
| Division Director |
Hetal Odobasic |
204-402-6540 |
| Assistant Director for Blood Pressure and Flow Devices |
LCDR Stephen Browning |
240-402-5241 |
| Assistant Director for Cardiac Ablation, Mapping, and Imaging Devices |
Aneesh Deoras |
240-402-4363 |
| Assistant Director for External Heart Rhythm and Rate Devices |
Jennifer Shih Kozen |
301-796-5813 |
| Assistant Director for Implantable Electrophysiology Devices |
Sara Royce |
204-402-6540 |
| Division of Health Technology 2 B (Circulatory Support, Structural and Vascular Devices) |
| Division Director |
Rachel Neubrander |
240-402-5086 |
| Assistant Director for Cardiac Occluders and Hemostasis Devices |
Katherine Trivedi (Acting) |
240-402-6398 |
| Assistant Director for Circulatory Support Devices |
Nicole Gillette |
240-402-6630 |
| Assistant Director for Heart Valve Devices |
Jamie Raben, Ph.D. |
301-796-6940 |
| 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: GastroRenal, ObGyn, General Hospital and Urology Devices) |
| Office Director |
Courtney Lias, Ph.D. |
301-796-5458 |
| Deputy Office Director |
Kristina Donohue |
N/A |
| Deputy Office Director |
Kellie Kelm, Ph.D. |
301-796-6145 |
| Division of Health Technology 3 A (Renal, Gastrointestinal, Obesity and Transplant Devices) |
| Division Director |
Glenn Bell, Ph.D. |
301-796-7030 |
| Assistant Director for Renal and Transplantation Devices |
Maura Rooney |
781-587-7531 |
| Assistant Director for Gastroenterology and Endoscopy Devices |
Shanil Haugen, Ph.D. |
301-796-0301 |
| Assistant Director for Obesity and Hepatobiliary Devices |
Anthony C. Lee |
240-402-5935 |
| Division of Health Technology 3 B (Reproductive, Gynecology and Urology Devices) |
| Division Director |
Sharon Andrews |
301-796-6529 |
| Assistant Director for Obstetrical and Reproductive Health Devices |
Monica Garcia, Ph.D. |
240-402-2791 |
| Assistant Director for Gynecological and Surgical Devices |
Jason Roberts, Ph.D. |
240-402-6400 |
| Assistant Director for Urological Devices |
Mark Antonino |
240-402-9980 |
| Assistant Director for Incontinence and Female Urological Devices |
Jessica Nguyen, Ph.D. |
301-796-6277 |
| Division of Health Technology 3 C (Drug Delivery and General Hospital Devices and Human Factors) |
| Division Director |
Juliane Lessard, Ph.D. |
240-402-6126 |
| Assistant Director for Injection Devices |
Shruti Mistry |
301-796-6605 |
| Assistant Director for Infusion Devices |
Jake Lindstrom, Ph.D. |
301-796-5716 |
| Assistant Director for General Hospital Devices |
David Wolloscheck, Ph.D. |
301-796-1480 |
| Assistant Director for Human Factors and Reliability Engineering |
Tania Reina |
301-221-7499 |
| Office of Health Technology 4 (OHT 4: Surgical and Infection Control Devices) |
| Office Director |
Binita Ashar, M.D. |
301-796-6970 |
| Deputy Office Director |
Vacant |
|
| Deputy Office Director |
Bleta Vuniqi |
301-796-5497 |
| Associate Director for Professional Development |
Melissa Eakle |
301-796-5425 |
| Division of Health Technology 4 A (General Surgery Devices) |
| Division Director |
Vacant |
|
| Assistant Director for Robotic Assisted Surgery Devices |
Mark Trumbore, Ph.D. |
301-796-5436 |
| Assistant Director for Non-Light Based Energy Devices |
Long Chen, Ph.D. |
301-796-6970 |
| Assistant Director for Light Based Energy Devices |
Tanisha Hithe |
301-796-5524 |
| Assistant Director for Cancer Diagnosis and Treatment Devices |
Jessica Carr, Ph.D. |
301-796-5997 |
| Division of Health Technology 4 B (Infection Control and Plastic and Reconstructive Surgery) |
| Division Director |
Cynthia Chang, Ph.D. |
301-796-6891 |
| Deputy Division Director |
Clarence Murray III, Ph.D. |
301-796-0270 |
| Assistant Director for Sterility Devices |
Christopher Dugard |
240-402-6031 |
| Assistant Director for Personal Protective Equipment, Reprocessing and Disinfection Devices |
Bifeng Qian |
301-796-2261 |
| Assistant Director for Plastic Surgery Implant Devices |
Tek Lamichhane, Ph.D. |
301-796-8983 |
| Assistant Director for Plastic Surgery Skin and Wound Devices |
Julie Morabito, Ph.D. |
240-402-3839 |
| Assistant Director for Implant Devices 2 |
Alicia Hemphill |
N/A |
| Assistant Director for Wound Devices |
Yu-Chieh Chiu, Ph.D. |
301-796-6196 |
| Assistant Director for Disinfection and Reprocessing Devices |
Katharine Segars, Ph.D. |
301-837-7144 |
| Office of Health Technology 5 (OHT 5: Neurological and Physical Medicine Devices) |
| Office Director |
David McMullen, M.D. |
301-796-1556 |
| Deputy Office Director |
John Marler, M.D. |
301-796-4221 |
| Deputy Office Director |
CAPT Nina Mezu-Nwaba,PharmD,MPH,MSc |
301-796-5494 |
| 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, Ph.D. |
240-402-6128 |
| Assistant Director for Acute Stroke Devices |
Naira Muradyan, Ph.D. |
240-402-4918 |
| Assistant Director for Neurodiagnostic Devices |
Jay Gupta |
240-402-3705 |
| Division of Health Technology 5 B (Neuromodulation and Rehabilitation Devices) |
| Division Director |
Vivek Pinto, Ph.D. |
301-796-1136 |
| Assistant Director for Neurostimulation-Neurology Devices |
CDR Jitendra Virani |
301-796-6398 |
| Assistant Director for Neuromodulation-Psychiatry Devices |
Pamela Scott |
301-796-5433 |
| Assistant Director for Acute Injury Devices |
Heather Dean, Ph.D. |
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, Ph.D. |
301-796-5650 |
| Deputy Office Director |
Marieann Brill |
240-402-3838 |
| Deputy Office Director |
Christopher Harner, M.D. |
301-796-5650 |
| Division of Health Technology 6 A (Joint Arthroplasty Devices) |
| Division Director |
Jiping Chen, M.D., Ph.D. |
301-796-6058 |
| Assistant Director for Knee Arthroplasty Devices |
Lixin Liu, Ph.D. |
301-796-3480 |
| Assistant Director for Hip Arthroplasty Devices |
Limin Sun, Ph.D. |
301-796-7056 |
| Assistant Director for Shoulder Arthroplasty Devices |
Farzana Sharmin, Ph.D. |
301-796-4067 |
| Division of Health Technology 6 B (Spinal Devices) |
| Division Director |
Ronald Jean, Ph.D. |
301-796-6408 |
| Assistant Director for Intracolumnar Spinal Devices |
Brent Showalter, Ph.D. |
240-402-1840 |
| Assistant Director for Extracolumnar Spinal Devices |
Colin O'Neill |
301-796-6428 |
| Division of Health Technology 6 C (Restorative, Repair and Trauma Devices) |
| Division Director |
Laurence Coyne, Ph.D. |
301-796-6450 |
| Assistant Director for Restorative, Repair, Trauma and Fracture Fixation Devices |
Jesse Muir, Ph.D. |
240-402-6679 |
| 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) |
| Office Director |
Courtney Lias, Ph.D. (Acting) |
301-796-5458 |
| Deputy Office Director |
Toby Lowe (Acting) |
301-796-6512 |
| Deputy Office Director |
Brittany Schuck, Ph.D. |
301-796-5199 |
| Deputy Office Director |
Ryan Lubert, J.D. (Acting) |
240-402-6357 |
| Division of Program Operations and Management |
| Division Director |
Amy Zale |
301-796-0869 |
| Deputy Division Director |
Vacant |
|
| Assistant Director for Laboratory Improvements, Outreach and Analysis |
Andrew Grove, Ph.D. |
301-796-6198 |
| Division of Chemistry and Toxicology Devices |
| Division Director |
Marianela Perez-Torres, Ph.D. |
301-796-1489 |
| Deputy Division Director |
Paula Caposino, Ph.D. (Acting) |
301-796-6160 |
| Branch Chief for Chemistry |
Thomas Miller, Ph.D. |
240-402-8938 |
| Branch Chief for Diabetes |
Joshua Balsam, Ph.D. |
240-402-6521 |
| Branch Chief for Toxicology |
Joseph Kotarek, Ph.D. |
301-796-2718 |
| 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 |
Min Wu, Ph.D. |
301-348-1886 |
| Branch Chief for Immunology and Flow Cytometry |
Ying Mao, Ph.D. |
301-796-6635 |
| Division of Molecular Genetics and Pathology |
| Division Director |
Donna Roscoe, Ph.D. (Acting) |
301-796-6183 |
| Deputy Division Director |
Donna Roscoe, Ph.D. |
301-796-6183 |
| Branch Chief for Molecular Pathology and Cytology |
Soma Ghosh, Ph.D. |
240-402-5333 |
| Deputy Branch Chief for Molecular Pathology and Cytology |
Shyam Kalavar, Ph.D. |
301-796-6807 |
| Branch Chief for Molecular Genetics |
Zivana Tezak, Ph.D. |
301-796-6206 |
| Deputy Branch Chief for Molecular Genetics |
Vacant |
|
| Division of Microbiology Devices |
| Division Director |
Uwe Scherf, Ph.D. |
301-796-5456 |
| Deputy Division Director |
Vacant |
|
| Branch Chief for Viral Respiratory and HPV |
Himani Bisht, Ph.D. |
301-796-6189 |
| Deputy Branch Chief for Viral Respiratory and HPV |
Joseph Briggs, Ph.D. |
240-402-7942 |
| Branch Chief for General Viral and Hepatitis |
Maria Garcia, Ph.D. |
301-796-7017 |
| Deputy Branch Chief for General Viral and Hepatitis |
Ryan Karsner, Ph.D. |
301-796-3336 |
| Branch Chief for General Bacterial and Antimicrobial Susceptibility |
Ribhi Shawar, Ph.D. |
301-796-6698 |
| Deputy Branch Chief for General Bacterial and Antimicrobial Susceptibility |
Leroy Hwang, Ph.D. |
240-402-6427 |
| Branch Chief for Bacterial Respiratory and Medical Countermeasures |
Noel Gerald, Ph.D. |
301-796-4695 |
| Deputy Branch Chief for Bacterial Respiratory and Medical Countermeasures |
Silke Schlottmann, Ph.D. |
301-796-9551 |
| Office of Health Technology 8 (OHT 8: Radiological Health) |
| Office Director |
Robert Ochs, Ph.D. |
301-796-6661 |
| Deputy Office Director |
Robert Sauer |
301-796-3580 |
| Deputy Office Director |
CDR David Dar |
301-796-5617 |
| Division of Health Technology 8 A (Mammography Quality Standards) |
| Division Director |
David Lee, M.D. |
301-796-4120 |
| Deputy Division Director |
Preetham Sudhaker |
301-796-5911 |
| Assistant Director for Program Management |
Normica Facey |
301-796-5914 |
| Assistant Director for Information Management |
Dennis L. Trammell |
301-796-5926 |
| Division of Health Technology 8 B (Radiological Imaging Devices and Electronic Products) |
| Division Director |
Laurel Burk, Ph.D. |
301-796-5933 |
| Deputy Division Director |
Vacant |
|
| Assistant Director for Diagnostic X-Ray Systems |
Lu Jiang, Ph.D. |
240-402-5779 |
| Assistant Director for Electronic Products |
Patrick Hintz |
N/A |
| Assistant Director for Imaging Software |
Jessica Lamb, Ph.D. |
301-796-6167 |
| Division of Health Technology 8 C (Radiological Imaging and Radiation Therapy Devices) |
| Division Director |
Julie Sullivan, Ph.D. |
240-402-4973 |
| Deputy Division Director |
Michael O'Hara, Ph.D. |
301-796-0294 |
| Assistant Director for Mammography and Ultrasound |
Yanna Kang, Ph.D. |
301-796-6704 |
| Assistant Director for Magnetic Resonance and Nuclear Medicine |
Daniel Krainak, Ph.D. |
301-796-0478 |
| Assistant Director for Radiation Therapy |
Lora Weidner, Ph.D. |
240-402-6424 |
