CDRH Management Directory by Organization
This information is current as of December 13, 2024
| Center Director | Michelle Tarver, M.D., Ph.D. | 301-796-5900 |
| Deputy Center Director for Science | Douglas Kelly, M.D. | 301-796-5900 |
| Deputy Center Director for Policy | Ellen Flannery, J.D. | 301-796-5900 |
| Deputy Center Director for Regulatory Operations | Owen Faris, Ph.D. | 301-796-6356 |
| Associate Director for Scientific and Regulatory Programs | Elizabeth Hillebrenner | 301-796-5900 |
| Deputy Office Director | Nancy Collazo-Braier, Ph.D | 301-796-5676 |
| Associate Director for International Affairs | Melissa Torres | 301-796-5576 |
| Associate Director for International Policy and Strategy | Kenneth Cavanaugh, Ph.D. | 301-796-6377 |
| Associate Director for TPLC Advisory Program (TAP) | Alan Baumel | 301-796-5900 |
| Associate Director for Strategic Communications | Nicole Ellis | 301-796-5900 |
| Quality Management Staff | ||
| Staff Director | Nancy Collazo-Braier, Ph.D. | 301-796-5676 |
| Assistant Director for Quality Management Systems | Olga Claudio, Ph.D. | 301-796-7608 |
| Assistant Director for Process Improvement | Cathy Oliveri | 301-796-5549 |
| Assistant Director for Customer Experience | Andrea Varea | |
| Office Director | Starlet Johnson, M.S.J. | 301-796-9414 |
| Deputy Office Director | Jodi Duckhorn | 301-796-9164 |
| Deputy Office Director | Alicia Witters | 301-796-5846 |
| Associate Director for Operations and Quality Management | Sharon M. Davis | 301-796-5717 |
| Program Management Operations Staff | ||
| Staff Director | Jacob York | 301-796-3408 |
| Office of Communication and Content Development | ||
| Office Director | Vacant | |
| Division of Communication | ||
| Division Director | Kemba Ford | 301-796-6682 |
| Deputy Division Director | Elizabeth Dooley | 240-402-4774 |
| Assistant Director for Center Engagement Campaigns Team | Nicole Jovel | 240-402-4234 |
| Assistant Director for Employee Content Development Team | Nicole Jovel | 240-402-4234 |
| Assistant Director for Center Initiatives Content Development Team | Kemba Ford (Acting) | 301-796-6682 |
| Assistant Director for Consumer Content Development Team | Kemba Ford (Acting) | 301-796-6682 |
| Assistant Director for Industry Content Development Team | Kemba Ford (Acting) | 301-796-6682 |
| Assistant Director for Safety Content Development Team | Kemba Ford (Acting) | 301-796-6682 |
| Executive Secretariat Team | Elizabeth Dooley | 240-402-4774 |
| Division of Information Disclosure | ||
| Division Director | Candace Davis | 240-402-3736 |
| Deputy Division Director | Anastazia "Stacy" Taylor | 240-402-3737 |
| Assistant Director for Freedom of Information Disclosure Team A1 | Leif Collins | 240-402-2121 |
| Assistant Director for Freedom of Information Disclosure Team A2 | Leif Collins | 240-402-2121 |
| Assistant Director for Freedom of Information Disclosure Team B1 | Anjelica Ruda | 240-402-5380 |
| Assistant Director for Freedom of Information Disclosure Team B2 | Anjelica Ruda | 240-402-5380 |
| Assistant Director for Special Projects Disclosures Team | Denise Wallace | N/A |
| Assistant Director for Special Projects Team C1 | Denise Wallace | N/A |
| Assistant Director for Special Projects Team C2 | Denise Wallace | N/A |
| Division of Digital Communication and Marketing | ||
| Division Director | Vacant | |
| Assistant Director for Audio/Visual and Public Meeting Team | Jonathan Eaton | 240-402-6193 |
| Assistant Director for Graphic Design Team | Kemba Ford (Acting) | 301-796-6682 |
| Assistant Director for Digital Strategy Team | Kemba Ford (Acting) | 301-796-6682 |
| Assistant Director for Studio Production Team | Jonathan Eaton | 240-402-6193 |
| Assistant Director for Web Team | Kemba Ford (Acting) | 301-796-6682 |
| Office of Training and Education | ||
| Office Director | Vacant | |
| Division of Employee Training and Development | ||
| Division Director | Kelly Morin | 240-402-2475 |
| Deputy Division Director | Vacant | |
| Assistant Director for Employee Development Team | Vacant | |
| Assistant Director for Technology and Learning Management Team | Samantha Gordon | 301-796-4894 |
| Division of Industry and Consumer Education | ||
| Division Director | Elias Mallis | 301-796-6216 |
| Deputy Division Director | Joseph Tartal | 301-796-5853 |
| Assistant Director for Postmarket Industry Education Team | Tonya Wilbon | 301-796-6224 |
| Assistant Director for Consumer Education Team | Tonya Wilbon | 301-796-6224 |
| Assistant Director for Premarket Industry Education Team | Michelle Sandrian | 240-402-4866 |
| Office Director and Executive Officer | Janelle Barth | 301-796-7320 |
| Deputy Officer Director and Deputy Executive Officer | Jaime Horman | 240-402-6176 |
| Associate Director | Sharron Wyatt | 240-402-6642 |
| Management Systems and Analysis | ||
| Director for Management Systems and Analysis | Jonathan Sauer | 301-796-7564 |
| Planning and Program Analysis Staff | ||
| Staff Director | Sharron Wyatt (Acting) | 240-402-6642 |
| Assistant Director for Employee Engagement and Organizational Development Team | Amina Gilyard, Ed.D | 240-402-5114 |
| Assistant Director for Inclusion and Wellness Strategy Team | Caron Walter | 301-796-0346 |
| Division of Acquisitions Services | ||
| Division Director | Salim (Kyle) Roberts, J.D. | 301-766-6685 |
| Deputy Division Director | Annmarie Keane | 301-348-1755 |
| Assistant Director for Acquisition | Christopher Scott | 240-478-2441 |
| Assistant Director for Acquisition and Planning | Joshua (Josh) Holliday | 301-796-1947 |
| Division of Management Services | ||
| Division Director | Danyiel D'Antonio | 301-796-5967 |
| Deputy Division Director | Ann Jenkins | 240-402-8081 |
| Assistant Director for Travel and Conference Management | Tamie Pate | 240-402-8676 |
| Assistant Director for Space and Facilities Management | Stephanie Hawk | 301-796-4113 |
| Assistant Director for Committee Management and Planning | CDR Daniel Bailey | 301-796-2452 |
| Division of Workforce Management | ||
| Division Director | Omar Ahmed | 240-678-3139 |
| Deputy Division Director | Nicole Waskin | 240-402-8548 |
| Assistant Director for Staffing Team A | Renita Farrington | 240-429-9205 |
| Assistant Director for Staffing Team B | Ryan Fitzgibbons | 301-796-1301 |
| Assistant Director for Human Capital Management | Kali Gamble-Porter | 240-402-8401 |
| Assistant Director for Special Programs | Shannon Bradbury | 240-402-8536 |
| Assistant Director for Ethics Team | Amir Berhannu, J.D. | 240-402-2110 |
| Division of Financial Management | ||
| Division Director | Patricia Carr | 240-402-8171 |
| Deputy Division Director | Jessica Ghajari (Pittman) | 240-402-5198 |
| Assistant Director for Budget Execution | Gurdanish Singh | 240-702-3897 |
| Assistant Director for Budget Formulation | Mark Needham | 240-402-9823 |
| Assistant Director for Financial Accountability | Jason Brookbank | 301-796-5498 |
| Director | Ellen Flannery, J.D. | 301-796-5900 |
| Deputy Office Director | Jonette Foy, Ph.D. | 301-796-6328 |
| Ombudsman | Abiy Desta | 301-796-0293 |
| Deputy Ombudsman | Ken Skodacek | 301-796-6364 |
| Associate Director for Guidance, Legislation and Special Projects | Vacant | |
| Associate Director for Regulatory Documents and Special Projects | Ariel Seeley, J.D., M.SC. | 301-796-8738 |
| Immediate Office | ||||
| Office Director | Ross (Rusty) Segan | 240-402-3780 | ||
| Principal Deputy Office Director | Vacant | |||
| 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 | ||
| 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 | ||
| Supervisor for Compliance and Quality Team 2 | Vacant | |||
| 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 | ||
| Assistant Director for Establishment Assessment Team 1 | Gina Brackett | N/A | ||
| Assistant Director for Establishment Assessment Team 2 | Melissa Michurski | N/A | ||
| Assistant Director for Establishment Assessment Team 3 | Mei Chen (Jessica) MU | 949-608-4477 | ||
| 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 | Vacant | N/A | ||
| Assistant Director for Outreach and Partnerships Team | 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) | ||||
| 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 (Bill) MacFarland | 301-796-5547 | ||
| Deputy Office Director | Misti Malone (Acting) | 301-796-2520 | ||
| 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 | Julie Morabito, Ph.D. | 240-402-3839 | ||
| 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 | ||
| 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 | Vacant | |||
| 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 | Xiaolin Zheng, Ph.D. | 301-796-2823 | ||
| 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 | Vacant | |||
| 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 | ||
| Assistant Director for Non-Fusion Spinal Devices Team | Ethan Naylor (Acting) | 301-837-7224 | ||
| 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 | ||
| Deputy Office Director | Christine Vietz | N/A | ||
| 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 | Vacant | |||
| 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 | Suso Platero | 240-402-5333 | ||
| Deputy Division Director | Soma Ghosh, Ph.D. (Acting) | 240-402-5333 | ||
| 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 | Anna Mielech (Acting) | 301-796-2479 | ||
| 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 | Bryan Grabias (Acting) | 240-402-9563 | ||
| 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 | Vacant | |||
| 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 | ||
| Office Director | Edward Margerrison, Ph.D. | 301-796-0262 |
| Deputy Office Director for Regulatory Engagement and Innovation | Anton E. Dmitriev, Ph.D. | 301-796-9596 |
| Associate Director for Strategic Initiative & Outreach | Dorn Carranza, Ph.D. | 301-796-8338 |
| Division of Administrative and Laboratory Support | ||
| Division Director | Angela Clingerman | 301-796-2569 |
| Deputy Division Director | Sara Sadaie | 301-796-2568 |
| Assistant Director for Laboratory Support | CDR David Bruno | 301-796-5930 |
| Division of Biology, Chemistry and Materials Science | ||
| Division Director | Michael Eppihimer, Ph.D. | 301-796-5340 |
| Deputy Division Director | Katherine Vorvolakos, Ph.D. | 301-796-2596 |
| Assistant Director for Chemical Characterization | Arghavan "Victoria" Nawaby, Ph.D. | 301-796-1514 |
| Assistant Director for Biocompability and Toxicology Team | Echoleah Rufer, Ph.D | 301-830-2907 |
| Division of Biomedical Physics | ||
| Division Director | Vacant | |
| Deputy Division Director | Daniel Hammer, Ph.D. | 301-796-4194 |
| Assistant Director for Electromagnetic and Electrical Safety | William Vogt, Ph.D. | 240-402-4142 |
| Assistant Director for Interoperable Patient Monitoring and Control Systems Team | Christopher Scully, Ph.D. | 301-796-2928 |
| Division of Applied Mechanics | ||
| Division Director | Genevieve McRae, Ph.D. | 301-796-6423 |
| Deputy Division Director | Prasanna Hariharan, Ph.D. | 301-796-2689 |
| Assistant Director for Orthopedics and Additive Manufacturing Team | Andrew Baumann, Ph.D. | 301-796-2508 |
| Assistant Director for Therapeutic Ultrasound Team | Subha Maruvada, Ph.D. | 301-796-2524 |
| Division of Imaging Diagnostics and Software Reliability | ||
| Division Director | Aldo Badano, Ph.D. | 301-796-2534 |
| Deputy Division Director | Nicholas Petrick, Ph.D. | 301-796-2563 |
| Deputy Division Director | Jana Delfino, Ph.D. | 301-796-6503 |
| Assistant Director for Software and High-Performance Computing | Kenny Cha, Ph.D. | 301-796-2858 |
| Assistant Director for Imaging Physics Team | Nirmal Soni, Ph.D. | 301-796-8581 |
| Office of Strategic Partnerships and Technology Innovation | ||
| Office Director | Suzanne Schwartz, M.D.,MBA | 301-796-6937 |
| Deputy Office Director | Linda Ricci, MME, MPH | 301-796-6325 |
| Deputy Office Director for Operations | Diane Mitchell, M.D. | 301-796-5423 |
| Associate Director for Data Modernization | Ali Russo, MPH | 240-328-7486 |
| Office of Readiness and Response | ||
| Office Director | Scott Colburn | 240-319-1456 |
| Deputy Office Director | Aftin Ross, Ph.D. | 301-796-5679 |
| Division of All Hazards Preparedness and Response | ||
| Division Director | Julia Madaras | 301-796-6000 |
| Division of Standards and Conformity Assessment | ||
| Division Director | Terry Woods, Ph.D. | 301-796-2503 |
| Assistant Director for Standards Management Program (SMP) | Jianchao Zeng, Ph.D. | 301-796-6580 |
| Assistant Director for Conformity Assessment Program (CAP) | Eric Franca, Ph.D. | 301-796-4505 |
| Division of Medical Device Cybersecurity | ||
| Division Director | Nastassia Tamari | N/A |
| Office of Equity and Innovative Development | ||
| Office Director | Terri Cornelison, M.D., Ph.D. | 301-796-5682 |
| Deputy Office Director | Vacant | |
| Division of Patient-Centered Development | ||
| Division Director | Cynthia Grossman | N/A |
| Deputy Division Director | Eva Rorer, M.D | 301-796-6461 |
| Division of Health Equity | ||
| Division Director | Vacant | |
| Division of Partnerships and Innovation | ||
| Division Director | Brittany Caldwell, Ph.D. | 301-348-3954 |
| Digital Health Center of Excellence | ||
| Office Director | Troy Tazbaz | N/A |
| Deputy Office Director | Sonja Fulmer, Ph.D. | 240-402-5979 |
| Chief Medical Officer for Digital Health Center of Excellence | Matthew Diamond, M.D., Ph.D. | 301-796-5386 |
| Division of Digital Health Policy | ||
| Division Director | Brittany "MiRa" Jacobs, Ph.D. | 240-402-6379 |
| Division of Digital Health Technology Assessment | ||
| Division Director | Catherine Bahr | 240-402-3413 |
| Division of Digital Health Outreach | ||
| Division Director | Michael Walker | N/A |
| Office of Technology and Data Services | ||
| Office Director | ||
| Deputy Office Director | Suzanne Rizzo | N/A |
| Division of Business Transformation Delivery | ||
| Division Director | Brian Kotula | 240-402-9914 |
| Division of Technology Services | ||
| Division Director | Dawn Stephens | N/A |
| Division of Data Services | ||
| Division Director | Vacant | |
| Office of Supply Chain Resilience | ||
| Office Director | Tammy Beckham, D.V.M, Ph.D. | N/A |
| Deputy Office Director | Carl Newman, Ph.D. | N/A |
| Division of Shortage Assessment and Product Authentication | ||
| Division Director | CAPT Matthew Brancazio | 301-796-5343 |
| Division of Prevention, Innovation and Resilience | ||
| Division Director | Vacant | |