Immediate Office |
Office Director |
Owen Faris (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 |
Supervisor for TPLC Fellowship Program Team 1 |
Michelle Chavis |
|
Supervisor for TPLC Fellowship Program Team 2 |
Jennifer Brown |
301-796-5626 |
Communications |
Associate Director |
Anne Hawthorn, J.D. |
301-796-6561 |
Operations Staff |
Associate Director |
Pamela Stanziani |
N/A |
Assistant Director |
Denise Hairston |
N/A |
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 Policy and Quality) |
Division Director |
Soma Kalb, Ph.D. |
301-796-5490 |
Deputy Division Director |
Ouided Rouabhi |
240-402-2672 |
Deputy Division Director |
Joshua Chetta |
240-402-4910 |
Assistant Director for Policy and Operations 1 |
Vacant |
|
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 (Clinical Science and Outreach) |
Division Director |
Katrina Jacobs (Acting) |
N/A |
Deputy Division Director |
Katrina Jacobs |
N/A |
Deputy Division Director |
Ozan Aygun, Ph.D. |
N/A |
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 |
Division of Clinical Evidence and Analysis 3 (Biostatistics I) |
Division Director |
Vacant |
|
Deputy Division Director |
Lily Yue, Ph.D. |
301-796-6033 |
Assistant Director for Biostatistics I Team A |
Yu “Audrey” Zhao, Ph.D. |
301-796-6165 |
Assistant Director for Biostatistics I Team B |
Vacant |
|
Assistant Director for Biostatistics I Team C |
Li Ming Dong |
240-402-6608 |
Assistant Director for Biostatistics I Team D |
Vacant |
|
Division of Clinical Evidence and Analysis 4 (Biostatistics II) |
Office Director |
Vacant |
|
Deputy Division Director |
Yun-Ling Xu, Ph.D. |
301-796-6031 |
Assistant Director for Biostatistics II Team A |
Xu "Sherry" Yan, Ph.D. |
301-796-6032 |
Assistant Director for Biostatistics II Team B |
Nelson Lu |
301-796-6018 |
Assistant Director for Biostatistics II Team C |
Hong “Laura” Lu, Ph.D. |
301-796-1699 |
Division of Clinical Evidence and Analysis 5 (Biostatistics III) |
Division Director |
Vacant |
|
Assistant Director for Biostatistics III Team A |
Rajesh Nair, Ph.D. |
301-796-6021 |
Assistant Director for Biostatistics III Team B |
Bipasa Biswas, Ph.D. |
301-796-5740 |
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 |
Vacant |
|
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 |
240-402-6398 |
Assistant Director for Circulatory Support Devices |
Nicole Gillette |
240-402-6630 |
Assistant Director for Heart Valve Devices |
Jennifer Kevit (Acting) |
240-402-3049 |
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 |
Kellie Kelm, Ph.D. (Acting) |
301-796-6145 |
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 |
Jamie Raben, Ph.D. (Acting) |
301-796-6940 |
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 (Plastic and Reconstructive Surgery) |
Division Director |
Cynthia Chang, Ph.D. |
301-796-6891 |
Deputy Division Director |
Kachikwu Illoh (Acting) |
N/A |
Assistant Director for Plastic and Reconstructive Surgery Devices Team 1 |
Alicia Hemphill |
N/A |
Assistant Director for Plastic and Reconstructive Surgery Devices Team 2 |
Tek Lamichhane, Ph.D. |
301-796-8983 |
Assistant Director for Plastic and Reconstructive Surgery Devices Team 3 |
Yu-Chieh Chiu, Ph.D. |
301-796-6196 |
Assistant Director for Plastic and Reconstructive Surgery Devices Team 4 |
Julie Morabito, Ph.D. |
240-402-3839 |
Division of Health Technology 4 C (Infection Control Devices) |
|
|
Division Director |
Vacant |
|
Assistant Director for Sterility Devices |
Christopher Dugard |
240-402-6031 |
Assistant Director for Personal Protective Equipment |
Bifeng Qian |
301-796-2261 |
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 |
Vacant |
|
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 |
Assistant Director for Neurointerventional Devices |
Sara Thompson |
N/A |
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 |
RDML 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 |
Assistant Director Bone-Soft Tissue Interface and Fracture Fixation Devices Team |
Christopher Ferreira |
301-796-9350 |
Office of Health Technology 7 (OHT 7: In Vitro Diagnostics) |
Office Director |
Courtney Lias, Ph.D. |
301-796-5458 |
Deputy Office Director |
Toby Lowe (Acting) |
301-796-6512 |
Deputy Office Director |
Brittany Schuck, Ph.D. |
301-796-5199 |
Chief Medical Officer & Associate Director for Medical Affairs |
Sara Brenner |
240-402-7533 |
Division of Program Operations and Management |
Division Director |
Amy Zale |
301-796-0869 |
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. |
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 |
Adam Ruben (Acting) |
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 |
Vacant |
|
Deputy Division Director |
Vacant |
|
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 |
Joseph Briggs, Ph.D. |
240-402-7942 |
Deputy Division Director |
Noel Gerald, Ph.D. |
301-796-4695 |
Branch Chief for Viral Respiratory and HPV |
Himani Bisht, Ph.D. |
301-796-6189 |
Deputy Branch Chief for Viral Respiratory and HPV |
Vacant |
|
Branch Chief for General Viral and Hepatitis |
Maria Garcia, Ph.D. |
301-796-7017 |
Deputy Branch Chief for General Viral and Hepatitis |
Jorge Munoz |
N/A |
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 |
Vacant |
|
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 |