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 |
Senior Project Manager |
Debra Grygier |
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 |
301-796-6610 |
Supervisor for Clinical and Scientific Policy Staff Team 1 |
Vacant |
|
Supervisor for Clinical and Scientific Policy Staff Team 2 |
Kimberly Brown Smith, M.D.,Ph.D |
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, Ph.D. |
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 |
301-796-6453 |
Assistant Director for 510(k), DeNovo, 513(g), Device Determinations and Custom Devices Lifecycle |
Vacant |
|
Assistant Director for PMA, HDE, Presubmission and Device Tracking Lifecycle |
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 |
Deniz Mackey |
301-796-5908 |
Assistant Director for Exports |
Leila M. Lawrence |
240-402-4020 |
Assistant Director for FDA Inspections and Regulatory Audits |
CDR Neil Mafnas |
240-402-4020 |
Division of Regulatory Programs 3 (Market Intelligence) |
Division Director |
Donna Engleman |
301-796-5530 |
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 |
Assistant Director for Lifecycle Program 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 |
Chief Medical Officer |
Charles Viviano, M.D., Ph.D. (Acting) |
|
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 |
Christian Suero, Ph.D |
301-796-8589 |
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 |
Rebecca Torguson |
301-796-3244 |
Deputy Division Director |
Hina Pinto (Acting) |
301-796-6351 |
Assistant Director Policy and Operations 1 |
Ouided Rouabhi (Acting) |
240-402-2672 |
Assistant Director for Clinical Evidence Quality 1 |
Marisa White (Acting) |
301-796-5653 |
Assistant Director for Clinical Evidence Quality 2 |
Sheena Green |
301-796-5490 |
Assistant Director for Methods, Analysis and Infrastructure 1 |
Dongyi (Tony) Du, M.D., Ph.D. |
240-402-4241 |
Assistant Director for Methods, Analysis and Infrastructure 2 |
Jiping Chen, M.D., Ph.D. |
301-796-6058 |
Assistant Director for Outreach and Partnerships 1 |
Alexandra Koustenis (Acting) |
301-796-6125 |
Assistant Director for Outreach and Partnerships 2 |
Julie Morabito, Ph.D. |
240-402-3839 |
Assistant Director for Clinical Evidence Outcomes Research |
Jacqueline Puigbo, Ph.D. |
240-402-0342 |
Division of Clinical Evidence and Analysis 2 (Biostatistics) |
Division Director |
Vacant |
|
Deputy Division Director |
Yun-Ling Xu, Ph.D. |
301-796-6031 |
Deputy Division Director |
Lilly Yue, Ph.D. |
301-796-6033 |
Deputy Division Director |
Vacant |
|
Assistant Director for Biostatistics 1 |
Xu (Sherry) Yan, Ph.D. |
301-796-6032 |
Assistant Director for Biostatistics 2 |
Chul Ahn, Ph.D. |
301-796-6026 |
Assistant Director for Biostatistics 3 |
Hong (Laura) Lu, Ph.D. |
301-796-1699 |
Assistant Director for Biostatistics 4 |
Rajesh Nair, Ph.D. |
301-796-6021 |
Assistant Director for Biostatistics 5 |
Bipasa Biswas, Ph.D. |
301-796-5740 |
Assistant Director for Biostatistics 6 |
Xuefeng.Li (Acting) |
301-796-6016 |
Assistant Director for Biostatistics 7 |
Vacant |
|
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 |
Vacant |
|
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 |
Kim Scarborough |
240-402-1343 |
Safety Signal Manager |
Allison O'Neill, Ph.D. |
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, 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 |
Anjana Jain (Acting) |
301-796-6363 |
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 |
Assistant Director for Anesthesia Devices |
Todd Courtney |
301-796-5580 |
Assistant Director for Respiratory Devices |
Brandon Blakely |
301-348-1958 |
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 |
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 |
Tara Smith |
301-796-2690 |
Associate Director Professional Development |
Melinda Hill |
|
Safety Signal Manager |
CDR Jennifer Danieley |
301-796-0309 |
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 |
LCDR Stephen Browning |
301-796-5540 |
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 |
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 |
Nicole Gillette |
240-402-6630 |
Assistant Director for Heart Valve Devices |
Jaime Raben |
301-796-1137 |
Assistant Director for Vascular and Endovascular Devices |
Carmen Gacchina, 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 |
Finn Donaldson (Acting) |
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 |
Joyce Whang, Ph.D. |
301-796-7030 |
Deputy Office Director |
Charles Viviano, M.D., Ph.D. |
240-402-2975 |
Chief Medical Officer |
Vacant |
|
Associate Director |
Ann Ferriter |
301-796-5686 |
Associate Director for Operations |
Christine Lee |
301-796-7030 |
Associate Director for Professional Development |
Michelle Chavis |
|
Safety Signal Manager |
Kathleen White |
301-796-5832 |
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 |
Gema Gonzalez (Acting) |
301-796-6519 |
Assistant Director for Gastroenterology and Endoscopy Devices |
Shanil Haugen, Ph.D. |
301-796-0301 |
Assistant Director for Obesity and Hepatobiliary Devices |
Je Hi An, Ph.D. |
240-402-0018 |
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 |
Tina Kiang, Ph.D. |
240-393-5776 |
Assistant Director for Injection Devices |
CAPT Alan Stevens |
301-796-6294 |
Assistant Director for Infusion Devices |
Vacant |
|
Assistant Director for General Hospital Devices |
Payal Patel |
240-402-6029 |
Assistant Director for Human Factors and Reliability Engineering |
Tania Reina |
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 |
301-769-5615 |
Chief Medical Science Officer |
Dorian Korz, M.D. |
301-796-4335 |
Associate Director for Operations |
LCDR Ogochukwu Ogoegbunam |
240-402-8807 |
Associate Director for Professional Development |
Melissa Eakle |
301-796-5530 |
Safety Signal Manager |
Irada Isayeva |
301-796-2618 |
Division of Health Technology 4 A (General Surgery Devices) |
Division Director |
Cynthia Long (Acting) |
301-796-6288 |
Assistant Director for Robotic Assisted Surgery Devices |
Mark Trumbore |
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 |
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 |
Clarence Murray III |
301-796-0270 |
Assistant Director for Personal Protective Equipment, Reprocessing and Disinfection Devices |
Vacant |
|
Assistant Director for Plastic Surgery Implant Devices |
Deborah Fellhauer |
301-796-9570 |
Assistant Director for Plastic Surgery Skin and Wound Devices |
Julie Morabito, Ph.D. (Acting) |
240-402-3839 |
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,PharmD |
301-796-5494 |
Chief Medical Officer |
Katrina Gwinn (Acting) |
240-402-2762 |
Associate Director |
Sergio de del Castillo |
301-796-6419 |
Associate Director for Operations |
Tonja Galberth |
301-796-5959 |
Associate Director for Professional Development |
Brian Lawrence |
323-873-7160 |
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, Ph.D. |
240-402-6128 |
Assistant Director for Neurointerventional Devices |
Naira Muradyan |
240-402-4918 |
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 |
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 |
301-796-5650 |
Deputy Office Director |
Marieann Brill (Acting) |
240-402-3838 |
Deputy Office Director |
Christopher Harner, M.D. |
301-796-5650 |
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 |
Alan Myers |
240-402-2867 |
Safety Signal Manager |
Hongying Jiang, Ph.D. |
301-796-6087 |
Division of Health Technology 6 A (Joint Arthroplasty Devices) |
Division Director |
Jiping Chen, M.D., Ph.D. (Acting) |
|
Assistant Director for Knee Arthroplasty Devices |
Ting Song |
301-796-7677 |
Assistant Director for Hip Arthroplasty Devices |
Limin Sun (Acting) |
301-796-7056 |
Assistant Director for Shoulder Arthroplasty Devices |
Vacant |
|
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 |
Ryan Lubert, Ph.D. (Acting) |
240-402-6357 |
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 |
Anne Poduska, Ph.D. |
240-402-0167 |
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 |
LCDR David Dar |
301-796-5617 |
Branch Chief for Laboratory Improvements, Outreach and Analysis |
Andrew Grove, Ph.D. |
301-796-6198 |
Branch Chief for Third Party 510(k) Program |
Vacant |
|
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. |
240-402-6126 |
Branch Chief for Diabetes |
Yiduo Wu |
301-796-2942 |
Branch Chief for Toxicology |
Joseph Kotarek (Acting) |
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 |
Vacant |
|
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 |
Deputy Branch Chief for Molecular Pathology and Cytology |
Vacant |
|
Branch Chief for Molecular Genetics |
Zivana Tezak |
301-796-6206 |
Deputy Branch Chief for Molecular Genetics |
Vacant |
|
Division of Microbiology Devices |
Director |
Uwe Scherf, Ph.D. |
301-796-5456 |
Deputy Director |
Kristian Roth, Ph.D. |
301-796-7024 |
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 |
Vacant |
|
Branch Chief for General Bacterial and Antimicrobial Susceptibility |
Ribhi Shawar, Ph.D. |
301-796-6698 |
Deputy Branch Chief for General Bacterial and Antimicrobial Susceptibility |
Vacant |
|
Branch Chief for Bacterial Respiratory and Medical Countermeasures |
Vacant |
|
Deputy Branch Chief for Bacterial Respiratory and Medical Countermeasures |
Vacant |
|
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 |
240-402-4973 |
Branch Chief for Mammography, Ultrasound and Imaging Software |
Jessica Lamb, Ph.D. |
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 |