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CDRH Management Directory by Organization

This information is current as of September 16, 2014.
 

Center Director: Jeffrey Shuren, M.D., J.D. 301-796-5900
Deputy Center Director for Science and CDRH Chief Scientist William Maisel, M.D., M.P.H. 301-796-5900
Associate Director for Science Vacant 301-796-5900
Assistant Director for Science Diane Mitchell, M.D. 301-796-5423
Deputy Center Director for Policy Vacant 301-796-5900
Associate Director for Policy Paul Gadiock, J.D. (Acting) 301-796-5736
Assistant Director for Guidance Management Ruth Fischer 301-796-5735
Associate Director for Management and Executive Officer Ruth E. Mckee 301-796-5515
Associate Director for Technology and Innovation Murray Sheldon, M.D 301-796-5443
Associate Director for International Affairs Kim Trautman 301-796-5515
Associate Director for External Relations Mary (Peper) Long 301-796-4671
Associate Director for Digital Health Bakul Patel (Acting)  
Chief Pediatric Medical Officer Vacant 301-796-5900
Director of Quality Management Nancy Braier, Ph.D. 301-796-5676
Ombudsman Vacant 301-796-5900
Deputy Ombudsman Michelle Sage (Acting) 301-706-6449
Business Information Solutions Paul Fisher 301-796-6176
Deputy Director Scott McCall 301-796-5304
External Expertise and Partnerships Anindita Saha 301-796-2537
Regulations Staff Nancy Pirt, J.D., M.P.H. 301-796-6248
Deputy Director Erica Blake (Acting) 301-796-3999
Standards Management Staff LCDR Scott Colburn 301-796-6287
Deputy Director Sharon Lappalainen 301-796-6322
Emergency Preparedness/Operations and
Medical Countermeasures Program
Suzanne Schwartz, M.D, MBA 301-796-6937
Program Management Officer Joanna King 301-796-5929
Director: Lynne L. Rice 301-796-5660
Deputy Director Heather D. Howell 301-796-5718
Associate Director for Program Operations Clifford D. Evans 301-796-6644
Associate Director for Internal Communications Joyce Siwarski 301-796-5422
Associate Director for Outreach and Review Mark H. Barnett 240-276-3970
Special Assistant to the Director Sharon Davis 301-796-5717
Digital Communication Media Staff
(formerly Division of Communication Media)
Chad Heupel 240-276-0922
Division of Employee Training and Development
(formerly Staff College)
Jacqueline Woodard 301-796-5670
Deputy Director Laura Stewart 301-796-5673
Division of Health Communication Laurel S. Mendelson 301-796-5764
Deputy Director Kristine Butler 301-796-5843
Strategic Communication Branch Alicia Witters 301-796-5846
Web Communication Branch Edie Seligson 301-796-5768
Division of Industry and Consumer Education (formerly Division of
Small Manufacturers, International and Consumer Assistance)
Elias Mallis 301-796-6216
Deputy Director William Sutton 301-796-5849
Postmarket and Consumer Branch Joseph Tartal 301-796-5853
Premarket Programs Branch Xiaoqiu Tang 301-796-5850
Division of Information Disclosure
(formerly Division of Freedom of Information)
Bill Holzerland 301-796-5897
Deputy Director Candace Boston 240-402-3736
Freedom of Information Branch A Anastazia Taylor 240-402-3737
Freedom of Information Branch B Latroy Tinch 301-796-5952
Director: Steven Silverman 301-796-5500
Deputy Director for Regulatory Affairs Jan Welch 301-796-5500
Deputy Director for Medical Affairs Kimber Richter 301-796-5500
Program Management Officer Marguerite Jones (Acting) 301-796-5807
Division of Analysis and Program Operations Ann Ferriter 301-796-5530
Deputy Director Melissa Eakle 301-796-5530
Deputy Director Vacant 301-796-5530
Registration and Risk Branch Dave Gartner 301-796-5530
Field Inspections Support Branch Tony Slater 301-796-5530
Recall Branch Ron Brown 301-796-5530
Allegations of Regulatory Misconduct Branch Donna Engleman 301-796-5530
Quality Management System and Executive Secretary Staff Frances Benedict 301-796-5530
Division of Bioresearch Monitoring Jim Saviola 301-796-5490
Deputy Director Linda Godfrey 301-796-5490
Bioresearch Compliance Branch I Veronica Calvin 301-796-5490
Bioresearch Compliance Branch II Adam Donat 301-796-5316
Division of Premarket and Labeling Compliance Stacie Bilek 301-796-5770
Deputy Director Keisha Thomas 301-796-5770
Surveillance and Enforcement Branch I LaShanda Long 301-796-5770
Surveillance and Enforcement Branch II Debra Demeritt 301-796-5770
Division of Manufacturing and Quality William (Bill) MacFarland 301-796-5540
Deputy Director Valerie Flournoy 301-796-5540
Cardiovascular Devices Branch Joshua Simms 301-796-5540
Physical Medicine, Orthopedic, Neurology & Dental Device Branch Matthew Krueger 301-796-5540
Abdominal and Surgical Device Branch Ronald Swann 301-796-5540
Respiratory, ENT, General Hospital, and Ophthalmic Device Branch Francisco Vicenty (Acting) 301-796-5577
Division of International Compliance Operations Vacant  
Deputy Director Vacant  
Foreign Enforcement Branch Daniel Walter 301-796-5587
Imports Branch Carole Jones 301-796-3194
Exports Branch Leila Lawrence 301-796-5786
Medical Device Single Audit Program Team Robert Ruff 301-796-6556
Director: William Maisel, M.D., M.P.H. (Acting) 301-796-5900
Deputy Director for Clinical Markham Luke, M.D., Ph.D. 301-796-5550
Deputy Director for Engineering & Science Review Jonette Foy, Ph.D. 301-796-5550
Deputy Director for Premarket Program Management Barbara Zimmerman 301-796-5550
Associate Director for Regulations and Guidance Angela Kruger 301-796-6341
Chief Medical Officer Randall Brockman 301-796-6316
Clinical Trial Director Owen Faris, Ph.D. (Acting) 301-796-6356
Advisory Panel Coordinator James Swink 301-796-5550
Director, Program Management Office Kathryn K. Appler 301-796-5560
Deputy Director, Program Management Office Sharyn (Lesa) A. Dowtin 301-796-5560
Premarket Approval Section Nicole Wolanski 301-796-5640
Investigational Device Exemption Section Soma Kalb, Ph.D. (Acting) 301-796-5640
Premarket Notification (510(k)) Section Marjorie Shulman 301-796-5640
Division of Anesthesiology, General Hospital, Respiratory,
Infection Control, and Dental Devices
Erin Keith 301-796-5580
Clinical Deputy Director Tejashri S. Purohit-Sheth, M.D. 301-796-5580
Scientific Deputy Director M. Susan Runner, D.D.S., MA (Acting) 301-796-5580
Anesthesiology Devices Branch Todd Courtney 301-796-5580
General Hospital Devices Branch Richard Chapman 301-796-5580
Respiratory Devices Branch Anya Harry, M.D., Ph.D. 301-796-5580
Infection Control Devices Branch Elizabeth Claverie 301-796-5580
Dental Devices Branch Sheena Green (Acting) 301-796-5580
Division of Cardiovascular Devices Bram D. Zuckerman, M.D. 301-796-7000
Deputy Director I OMitchell Shein (Acting) 301-796-7000
Deputy Director II Matthew Hillebrenner 301-796-7000
Associate Director Kenneth Cavanaugh 301-796-7000
Cardiac Diagnostics Devices Branch Linda Ricci 301-796-7000
Cardiac Electrophysiology Devices Branch Mark Fellman 301-796-7000
Circulatory Support Devices Branch Fernando Aguel 301-796-7000
Interventional Cardiology Devices Branch Melissa Torres 301-796-7000
Implantable Electrophysiology Devices Branch Ken Skodacek (Acting) 301-796-7000
Peripheral Interventional Devices Branch Sadaf Toor (Acting) 301-796-7000
Structural Heart Device Branch Erin Cutts (Acting) 301-796-6940
Vascular Surgery Devices Branch Nicole Ibrahim, Ph.D. (Acting) 301-796-6950
Division of Ophthalmic and Ear, Nose, and Throat Devices Malvina Eydelman, M.D. 301-796-5620
Scientific Deputy Director Kesia Alexander, Ph.D. 301-796-5620
Clinical Deputy Director Eric Mann, M.D., Ph.D. 301-796-5620
Associate Director Deborah Falls 301-796-5620
Contact Lenses and Retinal Devices Denise Hampton, Ph.D. 301-796-6860
Diagnostic and Surgical Devices Branch Bradley Cunningham 301-796-6620
Intraocular and Corneal Implants Branch Tina Kiang, Ph.D. 301-796-6860
Ear, Nose, and Throat Branch Srinivas Nandkumar, Ph.D 301-796-6620
Division of Neurological And Physical Medicine Devices Carlos Pena, Ph.D. 301-796-6610
Deputy Director I Felipe Aguel, Ph.D. 301-796-6610
Neurostimulation Devices Branch Timothy Marjenin 301-796-6610
Neurodiagnostic and Neurosurgical Devices Branch Quynh Hoang 301-796-6610
Physical Medicine and Neurotherapeutic Devices Branch Michael Hoffmann 301-796-6610
Division of Orthopedic Devices Mark Melkerson 301-796-5650
Deputy Director I Lori Wiggins (Acting) 301-796-5650
Deputy Director II Vacant 301-796-5650
Joint Fixation Devices Branch One Casey Hanley, Ph.D. 301-796-5650
Joint Fixation Devices Branch Two Elizabeth Kunkoski 301-796-5650
Restorative and Repair Devices Branch Laurence Coyne, Ph.D 301-796-5650
Anterior Spine Devises Branch Vacant 301-796-5650
Posterior Spine Devices Branch Ronald Jean, Ph.D 301-796-5650
Division of Surgical Devices Binita Ashar, M.D. (Acting) 301-796-6970
Deputy Director I David Krause, Ph.D.  
Deputy Director II Vacant  
General Surgery Devices Branch One Neil Ogden 301-796-6970
General Surgery Devices Branch Two Joshua Nipper 301-796-6970
Plastics and Reconstructive Surgery Devices Branch One Peter Hudson, Ph.D. 301-796-6970
Plastics and Reconstructive Surgery Devices Branch Two Jiyoung Dang, Ph.D. 301-796-6970
Division of Reproductive, Gastro-Renal, and Urological Devices Benjamin Fisher, Ph.D. 301-796-7030
Clinical Deputy Director Herbert Lerner, M.D. 301-796-7030
Scientific Deputy Director Joyce Whang, Ph.D. 301-796-7030
Obstetrics/Gynecology Devices Branch Elaine Blyskun 301-796-7030
Urology and Lithotripsy Devices Branch Glenn Bell, Ph.D. 301-796-7030
Renal Devices Branch Carolyn Neuland, Ph.D. 301-796-7030
Gastroenterology Devices Branch Jeffrey Cooper, DVM 301-796-7030
Director: Alberto Gutierrez, Ph.D. 301-796-5453
Deputy Director, New Product Evaluation Donald St. Pierre 301-796-5454
Deputy Director, Patient Safety and Product Quality James L. Woods 301-796-6225
Deputy Director, Radiological Health Mary S. Pastel, Sc.D. 301-796-6887
Chief Medical Officer Robert L. Becker, Jr., M.D. 301-796-5450
Chief Medical Officer for Radiological Health Donald L. Miller, M.D. 301-796-3299
Director, Personalized Medicine Staff Elizabeth A. Mansfield, Ph.D. 301-796-4664
Division of Program Operations and Management David (Duffy) Warren 301-796-6223
Deputy Director Brendan O'Leary 301-796-6898
Program Management Officer Debra Cooper 301-796-7553
Division of Chemistry and Toxicology Devices Courtney C. Lias, Ph.D. 301-796-5458
Deputy Director for Chemistry Carol C. Benson 301-796-5459
Chemistry Branch Yung W. Chan 301-796-6138
Diabetes Branch Stacy E. Beck, Ph.D. 301-796-6514
Toxicology Branch Denise N. Johnson-Lyles, Ph.D. 301-796-6169
Cardio-renal Diagnostics Branch Ruth Chesler 301-796-6140
Division of Immunology and Hematology Devices Maria M. Chan, Ph.D. 301-796-5482
Deputy Director Vacant  
Hematology Branch Leonthena R. Carrington 301-796-6164
Immunology and Flow Cytometry Branch Elizabeth A. Stafford, Ph.D. 301-796-6184
Division of Molecular Genetics and Pathology Reena Philip, Ph.D. 301-796-6179
Deputy Director Vacant  
Molecular Pathology and Cytology Branch Yun-Fu Hu, Ph.D. 301-796-6170
Molecular Genetics Branch Donna Roscoe, Ph.D. 301-796-6183
Division of Microbiology Devices Sally A. HojXXvat, Ph.D. 301-796-5455
Deputy Director Uwe Scherf, Ph.D. 301-796-5456
Viral Respiratory and HPV Branch Tamara V. Feldblyum, Ph.D. 301-796-6195
General Viral and Hepatitis Branch Stephen J. Lovell, Ph.D. 301-796-6968
General Bacterial and Antimicrobial Susceptibility Branch Ribhi Shawar, Ph.D. 301-796-6698
Bacterial Respiratory and Medical Countermeasures Branch John P. Hobson, Ph.D. 301-796-5892
Division of Radiological Health Janine M. Morris, M.S. 301-796-5706
Deputy Director Michael O’Hara, Ph.D. 301-796-0294
Deputy Director CAPT Sean M. Boyd, MPH, USPHS 301-796-5895
Magnetic Resonance and Electronic Products Branch Robert J. Doyle 301-796-5863
Diagnostic X-Ray Systems Branch Thalia T. Mills, Ph.D. 301-796-6641
Nuclear Medicine and Radiation Therapy Branch William Jung, Ph.D. 301-796-6228
Mammography, Ultrasound and Imaging Software Branch Robert Ochs, Ph.D. 301-796-6661
Division of Mammography Quality Standards Mary Pastel, Sc.D. (Acting) 301-796-6887
Deputy Director Timothy J. Haran 301-796-6625
Program Management Branch Preetham R. Sudhaker 301-796-5911
Information Management Branch Dennis L. Trammell 301-796-5926
Director: Frank Benedetti 301-796-5449
Deputy Director Daniel Montgomery 301-796-5987
Program Management Officer Joanna King 301-796-5929
Division of Ethics and Management Operations Stacey Wilson 301-796-5970
Deputy Director Danyiel D'Antonio 301-796-5967
Occupational Health and Safety Officer James Speckhart 301-796-3366
Occupational Health and Safety Officer Alexa Deptola 301-796-5925
Administrative Management Branch Diana Rivi 301-796-6124
Integrity, Committee and Conference Management Branch Kathleen Walker 301-796-5964
Division of Planning, Analysis, & Finance Carla Jones 301-796-5987
Deputy Director Vacant  
Planning Branch Noni Buchanan 301-766-5985
Financial Management Branch Cornell Hudson 301-796-5435
Director: Steven Pollack, Ph.D. 301-796-2530
Deputy Director for Program Policy and Evaluation Subhas Malghan, Ph.D. 301-796-2548
Deputy Director for Science Evaluation and Coordination Joel Myklebust, P.E., Ph.D. 301-796-2491
Associate Director for Regulatory Science Research Programs Donna Lochner 301-796-6309
Associate Director for Clinical Science Marilyn Lightfoote, Ph.D. 301-796-2556
Associate Director for Premarket Regulatory Science Erica Takai 301-796-6353
Associate Director for Engineering and Quality Management Alford Taylor Jr. 301-796-2583
Associate Director for Regulatory Science and Innovation Outreach Dinesh Patwardhan, Ph.D. 301-796-2622
Associate Office Directory for Laboratories Charles Warr 301-796-2556
Division of Administrative and Laboratory Support Angie Clingerman 301-796-2569
Deputy Director Rhonda Rhones 301-796-2679
Deputy Director Kevin Milne 301-796-2516
Division of Biology, Chemistry and Material Sciences Subhas Malghan, Ph.D. (Acting) 301-796-2548
Deputy Director Benita Dair-Chen, Ph.D. 301-796-2614
Deputy Director Peter Goering, Ph.D. (Acting) 301-796-0253
Division of Biomedical Physics Victor Krauthamer, Ph.D. 301-796-2474
Deputy Director Brian Beard, Ph.D. 301-796-2469
Deputy Director Daniel X. Hammer, Ph.D. 301-796-9320
Division of Applied Mechanics Anton Dimitriev, Ph.D. 301-796-2499
Deputy Director Jon Casamento 301-796-2499
Deputy Director Vacant  
Division of Imaging Diagnostics and Software Reliability Kyle Myers, Ph.D. 301-796-2533
Deputy Director Nicolas Petrick, Ph.D. 301-796-2563
Deputy Director Vacant  
Director: Thomas Gross, M.D. 301-796-5997
Deputy Director of Clinical Affairs and Chief Medical Officer Aron Yustein, M.D. 301-796-6006
Deputy Director for Policy and Administration Tahseen Mirza, Ph.D. 301-796-7645
Associate Director for Policy and Communications Anita Rayner 301-796-6002
Program Management Staff Valarie Rojas (Acting) 301-796-5994
Director of Knowledge Management Ramin Assa 301-796-6064
Associate Director Informatics Section Terrie Reed, MSIE 301-796-6130
Division of Patient Safety Partnerships Jill Marion (Acting) 301-796-6118
Deputy Director Jill Marion 301-796-6118
Associate Director for Surveys Tosia Hazlett 301-796-6119
Clinical Outreach Branch I Michael El-Shammaa 301-796-5302
Clinical Outreach Branch II Vacant 301-796-6128
Division of Epidemiology Danica Marinac-Dabic, Ph.D., M.D. 301-796-6689
Associate Director for Program Operations Nicole Jones 301-796-6062
Associate Director Nilsa Loyo-Berrios, Ph.D. 301-796-6065
Associate Director Daniel Canos 301-796-6057
Epidemiology Evaluation and Research Branch I Vacant  
Epidemiology Evaluation and Research Branch II Vacant  
Epidemiology Evaluation and Research Branch III Megan Gatski 301-796-0342
Division of Postmarket Surveillance Isaac Chang, Ph.D. 301-796-2789
Deputy Director Steven Chasin, Ph.D. 301-796-6053
Associate Clinical Director Nancy Pressly 301-796-5437
Associate Director, Medical Officer Vacant  
Product Evaluation Branch I Greg O'Connell 301-796-6075
Product Evaluation Branch II Charles Kern 301-796-6271
Product Evaluation Branch III Vacant  
Information Analysis Branch John-William Declaris 301-796-5437
MDR Policy Branch Sharon Kapsch 301-796-6104
Division of Biostatistics Greg Campbell, Ph.D. 301-796-5750
Deputy Director Gerry Gray, Ph.D. 301-796-6012
Deputy Director Lilly Yue, Ph.D. 301-796-6033
Cardiovascular and Ophthalmic Devices Branch Yunling Xu, Ph.D. 301-796-6033
Diagnostic Devices Branch Lakshmi Vishnuvajjala, Ph.D. 301-796-6042
General Surgical Devices Branch Telba Irony, Ph.D. 301-796-6044

Page Last Updated: 09/16/2014
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