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CDRH Management Directory by Organization

This information is current as of April 4, 2014

Office of the Center Director
Center Director:Jeffrey Shuren, M.D., J.D.301-796-5900
Deputy Center Director for Science and CDRH Chief ScientistWilliam Maisel, M.D., M.P.H.301-796-5900
Associate Director for ScienceMichelle McMurry-Heath, M.D., Ph.D.301-796-7647
Deputy Center Director for PolicyNancy Stade, J.D.301-796-5900
Associate Director for PolicyPhilip Desjardins, J.D.301-796-5678
Associate Director for Technology and InnovationMurray Sheldon, M.D301-796-5443
Assistant Director for ScienceDiane Mitchell, M.D.301-796-5423
Associate Director for Management and Executive OfficerRuth E. McKee301-796-5900
Associate Director for International AffairsKim Trautman301-796-5515
Associate Director for External RelationsMary (Peper) Long301-796-4671
Chief Pediatric Medical OfficerVacant 
Ombudsman/Quality Assurance ManagerDavid Buckles, Ph.D.301-796-5447
Business Information SolutionsPaul Fisher301-796-6176
Deputy DirectorScott McCall301-796-5304
External Expertise and PartnershipsAnindita Saha (Acting)301-796-2537
Regulations StaffNancy Pirt, J.D., M.P.H.301-796-6248
Deputy DirectorPaul Gadiock, J.D.301-796-5736
Standards Management StaffLCDR Scott Colburn301-796-6287
Deputy DirectorSharon Lappalainen301-796-6322
Emergency Preparedness/Operations & Medical Countermeasures ProgramSuzanne Schwartz, M.D, MBA301-796-6937
Program Management OfficerJoanna King301-796-5929
Office of Management Operations
Director:Frank Benedetti301-796-5449
Deputy DirectorDaniel Montgomery301-796-5987
Program Management OfficerJoanna King301-796-5929
Division of Ethics and Management OperationsSandy Roderick-Molina301-796-5970
Deputy DirectorDanyiel D'Antonio301-796-5967
Occupational Health and Safety OfficerTom Vegella301-796-2783
Occupational Health and Safety OfficerAlexa Deptola301-796-5925
Administrative Management BranchDiana Rivi301-796-6124
Integrity, Committee and Conference Management BranchKathleen Walker301-796-5964
Division of Planning, Analysis, & FinanceCarla Jones301-796-5987
Deputy DirectorKim Worthington301-796-5990
Planning BranchNoni Buchanan301-766-5985
Financial Management BranchCornell Hudson301-796-5435
Office of Compliance
Director:Steven Silverman301-796-5500
Deputy Director for Regulatory AffairsJan Welch301-796-5500
Deputy Director for Medical AffairsKimber Richter301-796-5500
Program Management OfficerCarolyn Bell301-796-5500
Division of Analysis and Program OperationsAnn Ferriter301-796-5530
Deputy DirectorMelissa Eakle301-796-5530
Deputy DirectorVacant301-796-5530
Registration and Risk BranchDave Gartner301-796-5530
Field Inspections Support BranchTony Slater301-796-5530
Recall BranchRon Brown301-796-5530
Allegations of Regulatory Misconduct BranchDonna Engleman301-796-5530
Quality Management System and Executive Secretary StaffFrances Benedict301-796-5530
Division of Bioresearch MonitoringJim Saviola301-796-5490
Deputy DirectorLinda Godfrey301-796-5490
Bioresearch Compliance Branch IVeronica Calvin301-796-5490
Bioresearch Compliance Branch IIAnne Hawthorn301-796-5490
Division of Premarket and Labeling ComplianceStacie Bilek301-796-5770
Deputy DirectorKeisha Thomas301-796-5770
Surveillance and Enforcement Branch ILaShanda Long301-796-5770
Surveillance and Enforcement Branch IIDebra Demeritt301-796-5770
Division of Manufacturing and QualityWilliam (Bill) MacFarland301-796-5540
Deputy DirectorValerie Flournoy301-796-5540
Cardiovascular Devices BranchJoshua Simms301-796-5540
Orthopedic, Neurology and Dental Device BranchMatthew Krueger301-796-5540
Abdominal and Surgical Device BranchRonald Swann301-796-5540
Respiratory, ENT, General Hospital, and Ophthalmic Device BranchCarl Fischer301-796-5540
Division of International Compliance OperationsVacant 
Deputy DirectorVacant 
Foreign Enforcement BranchDaniel Walter 
Imports BranchCarole Jones 
Exports BranchLeila Lawrence 
Medical Device Single Audit Program TeamRobert Ruff 
Office of Device Evaluation
Director:Christy Foreman301-796-5550
Deputy Director for ClinicalMarkham Luke, M.D., Ph.D.301-796-5550
Deputy Director for Engineering & Science ReviewJonette Foy, Ph.D.301-796-5550
Deputy Director for Premarket Program ManagementBarbara Zimmerman301-796-5550
Associate Director for Regulations and GuidanceVacant 
Associate Director, Chief Medical OfficerRandall Brockman301-796-5550
Clinical Trial DirectorOwen Faris, Ph.D. (Acting)301-796-5550
Advisory Panel CoordinatorJames Swink301-796-5550
Director, Program Management OfficeKathryn K. Appler301-796-5560
Deputy Director, Program Management OfficeSharyn (Lesa) A. Dowtin301-796-5560
Premarket Approval SectionNicole Wolanski301-796-5640
Investigational Device Exemption SectionSoma Kalb, Ph.D. (Acting)301-796-5640
Premarket Notification (510(k)) SectionMarjorie Shulman301-796-5640
Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental DevicesErin Keith (Acting)301-796-5580
Clinical Deputy DirectorTejashri S. Purohit-Sheth, M.D.301-796-5580
Scientific Deputy DirectorKwame Ulmer301-796-5580
Anesthesiology Devices BranchTodd Courtney (Acting)301-796-5580
General Hospital Devices BranchRichard Chapman301-796-5580
Respiratory Devices BranchAnya Harry, M.D.301-796-5580
Infection Control Devices BranchElizabeth Claverie301-796-5580
Dental Devices BranchM. Susan Runner, D.D.S., MA301-796-5580
Division of Cardiovascular DevicesBram D. Zuckerman, M.D.301-796-7000
Deputy Director IMitchell Shein (Acting)301-796-7000
Deputy Director IIMatthew Hillebrenner301-796-7000
Cardiac Diagnostics Devices BranchLinda Ricci301-796-7000
Cardiac Electrophysiology Devices BranchMark Feliman (Acting)301-796-7000
Circulatory Support Devices BranchFernando Aguel301-796-7000
Interventional Cardiology Devices BranchMelissa Torres301-796-7000
Implantable Electrophysiology Devices BranchMitchell Shein301-796-7000
Peripheral Interventional Devices BranchLisa Lim, Ph.D.301-796-7000
Structural Heart Device BranchErin Cutts (Acting)301-796-7000
Vascular Surgery Devices BranchNicole Ibrahim, Ph.D. (Acting)301-796-7000
Division of Ophthalmic and Ear, Nose, and Throat DevicesMalvina Eydelman, M.D.301-796-5620
Scientific Deputy DirectorKesia Alexander, Ph.D.301-796-5620
Clinical Deputy DirectorEric Mann, M.D., Ph.D.301-796-5620
Associate DirectorDeborah Falls301-796-5620
Contact Lenses and Retinal DevicesDenise Hampton, Ph.D.301-796-5620
Chief Ophthalmic Medical OfficerEva Rorer301-796-5620
Diagnostic and Surgical Devices BranchBrad Cunningham301-796-5620
Intraocular and Corneal Implants BranchTina Kiang, Ph.D.301-796-5620
Ear, Nose, and Throat BranchSrinivas Nandkumar, Ph.D301-796-5620
Division of Neurological And Physical Medicine DevicesCarlos Pena, Ph.D.301-796-6610
Deputy DirectorFelipe Aguel, Ph.D.301-796-6610
Assistant Director for Program OperationsColleen Lee301-796-6576
Neurostimulation Devices BranchTimothy Marjenin301-796-6610
Neurodiagnostic and Neurosurgical Devices BranchQuynh Hoang301-796-6610
Physical Medicine Devices BranchMichael Hoffmann301-796-6610
Division of Orthopedic DevicesMark Melkerson301-796-5650
Deputy Director ILori Wiggins (Acting)301-796-5650
Deputy Director IIPeter Rumm, M.D.301-796-5650
Joint Fixation Devices Branch OneCasey Hanley, Ph.D.301-796-5650
Joint Fixation Devices Branch TwoElizabeth Kunkoski301-796-5650
Restorative and Repair Devices BranchLaurence Coyne, Ph.D301-796-5650
Anterior Spine Devises BranchAnton Dmitriev, Ph.D.301-796-5650
Posterior Spine Devices BranchRonald Jean, Ph.D301-796-5650
Division of Surgical DevicesBinita Ashar, M.D. (Acting)301-796-5650
Deputy Director IDavid Krause, Ph.D.301-796-5650
Deputy Director IIVacant301-796-5650
General Surgery Devices Branch OneNeil Ogden301-796-5650
General Surgery Devices Branch TwoJoshua Nipper301-796-5650
Plastics and Reconstructive Surgery Devices Branch OnePeter Hudson, Ph.D. (Acting)301-796-5650
Plastics and Reconstructive Surgery Devices Branch TwoJiyoung Dang, Ph.D.301-796-5650
Division of Reproductive, Gastro-Renal, and Urological DevicesBenjamin Fisher, Ph.D.301-796-7030
Clinical Deputy DirectorHerbert Lerner, M.D.301-796-7030
Scientific Deputy DirectorJoyce Whang, Ph.D.301-796-7030
Obstetrics/Gynecology Devices BranchElaine Blyskun301-796-7030
Urology and Lithotripsy Devices BranchGlenn Bell, Ph.D.301-796-7030
Renal Devices BranchCarolyn Neuland, Ph.D.301-796-7030
Gastroenterology Devices BranchJeffrey Cooper, DVM301-796-7030
Office of In Vitro Diagnostics and Radiological Health
Director:  Alberto Gutierrez, Ph.D.301-796-5453
Deputy Director, New Product EvaluationDonald St. Pierre301-796-5454
Deputy Director, Patient Safety and Product QualityJames L. Woods301-796-6225
Deputy Director, Radiological HealthMary S. Pastel, Sc.D.301-796-6887
Chief Medical OfficerRobert L. Becker, Jr., M.D.301-796-5450
Chief Medical Officer for Radiological HealthDonald L. Miller, M.D.301-796-3299
Director, Personalized Medicine StaffElizabeth A. Mansfield, Ph.D.301-796-4664
Division of Program Operations and ManagementDavid (Duffy) Warren301-796-6223
Deputy DirectorJean M. Cooper, D.V.M. (Acting)301-796-5672
Program Management OfficerDebra Cooper301-796-7553
Division of Chemistry and Toxicology DevicesCourtney C. Lias, Ph.D.301-796-5458
Deputy Director for ChemistryCarol C. Benson301-796-5459
Chemistry BranchYung W. Chan301-796-6138
Diabetes BranchStacy E. Beck, Ph.D. (Acting)301-796-6514
Toxicology BranchDenise N. Johnson-Lyles, Ph.D.301-796-6169
Cardio-renal Diagnostics BranchRuth Chesler301-796-6140
Division of Immunology and Hematology DevicesMaria M. Chan, Ph.D.301-796-5482
Deputy DirectorReena Philip, Ph.D.301-796-6179
Hematology BranchLeonthena R. Carrington301-796-6164
Immunology and Flow Cytometry BranchElizabeth A. Stafford, Ph.D. (Acting)301-796-6184
Molecular Pathology and Cytology BranchYun-Fu Hu, Ph.D.301-796-6170
Immunological/Hematological Genetic Disorders BranchDonna M. Roscoe, Ph.D.301-796-6183
Division of Microbiology DevicesSally A. Hojvat, Ph.D.301-796-5455
Deputy DirectorUwe Scherf, Ph.D.301-796-5456
Viral Respiratory and HPV BranchTamara V. Feldblyum, M.S.301-796-6195
General Viral and Hepatitis BranchStephen J. Lovell, Ph.D.301-796-6968
General Bacterial and Antimicrobial Susceptibility BranchRibhi Shawar, Ph.D.301-796-6698
Bacterial Respiratory and Medical Countermeasures BranchJohn P. Hobson, Ph.D.301-796-5892
Division of Radiological HealthJanine M. Morris, M.S.301-796-5706
Deputy DirectorMichael O’Hara, Ph.D.301-796-0294
Deputy DirectorCAPT Sean M. Boyd, MPH, USPHS301-796-5895
Magnetic Resonance and Electronic Products BranchRobert J. Doyle301-796-5863
Diagnostic X-Ray Systems BranchThalia T. Mills, Ph.D.301-796-6641
Nuclear Medicine and Radiation Therapy BranchMarkus Yap, Ph.D.301-796-7347
Mammography, Ultrasound and Imaging Software BranchRobert Ochs, Ph.D.301-796-6661
Division of Mammography Quality StandardsMary Pastel, Sc.D. (Acting)301-796-6887
Deputy DirectorTimothy J. Haran301-796-6625
Program Management BranchPreetham R. Sudhaker301-796-5911
Information Management BranchDennis L. Trammell301-796-5926
Office of Surveillance and Biometrics 
Director:Thomas Gross, M.D.301-796-5997
Deputy Director of Clinical Affairs and Chief Medical OfficerAron Yustein, M.D.301-796-6006
Deputy Director for Policy and AdministrationTahseen Mirza, Ph.D.301-796-7645
Associate Director for Policy and CommunicationsAnita Rayner301-796-6002
Program Management StaffValarie Rojas (Acting)301-796-5994
Director of Knowledge ManagementRamin Assa301-796-6064 
Associate Director Informatics SectionTerrie Reed, MSIE301-796-6130
Division of Patient Safety PartnershipsJill Marion (Acting)301-796-6118
Deputy DirectorJill Marion301-796-6118
Associate Director for SurveysTosia Hazlett301-796-6119
Clinical Outreach Branch IMichael El-Shammaa301-796-5302
Clinical Outreach Branch IIVacant301-796-6128
Division of EpidemiologyDanica Marinac-Dabic, Ph.D., M.D.301-796-6689
Associate Director for Program OperationsNicole Jones301-796-6062
Associate Director, Post-Approval StudiesNilsa Loyo-Berrios, Ph.D.301-796-6065
Associate Director, Section 522 StudiesDaniel Canos301-796-6057
Epidemiology Evaluation and Research Branch IVacant 
Epidemiology Evaluation and Research Branch IIVacant 
Epidemiology Evaluation and Research Branch IIIMegan Gatski301-796-0342
Division of Postmarket SurveillanceIsaac Chang, Ph.D.301-796-2789
Deputy DirectorSteven Chasin, Ph.D.301-796-6053
Associate Clinical DirectorNancy Pressly301-796-5437
Associate Director, Medical OfficerVacant 
Product Evaluation Branch IGreg O'Connell301-796-6075
Product Evaluation Branch IICharles Kern301-796-6271
Product Evaluation Branch IIIVacant 
Information Analysis BranchJohn-William Declaris301-796-5437
MDR Policy BranchSharon Kapsch301-796-6104
Division of BiostatisticsGreg Campbell, Ph.D.301-796-5750
Deputy DirectorGerry Gray, Ph.D.301-796-6012
Deputy DirectorLilly Yue, Ph.D.301-796-6033
Cardiovascular and Ophthalmic Devices BranchYunling Xu, Ph.D.301-796-6033
Diagnostic Devices BranchLakshmi Vishnuvajjala, Ph.D.301-796-6042
General Surgical Devices BranchTelba Irony, Ph.D.301-796-6044
Office of Science and Engineering Laboratories
Director:Steven Pollack, Ph.D.301-796-2530
Deputy Director for Program Policy and EvaluationSubhas Malghan, Ph.D.301-796-2548
Deputy Director for Science Evaluation and CoordinationJoel Myklebust, P.E., Ph.D.301-796-2491
Associate Director for Scientific Outreach and CoordinationDonna Lochner301-796-6309
Associate Office Director for LaboratoriesCharles Warr301-796-2556
Associate Director for Premarket Regulatory ScienceErica Takai301-796-6353
Management Support StaffAngie Clingerman301-796-2569
Deputy DirectorGail Strieter301-796-3949
Division of BiologyMarilyn M. Lightfoote, M.D.301-796-0235
Deputy DirectorKevin Milne (Acting)301-796-2516
Division of Physics  Victor Krauthamer301-796-2474
Deputy DirectorBrian Beard, Ph.D.301-796-2469
Deputy DirectorDaniel X. Hammer, Ph.D.301-796-9320
Division of Solid and Fluid MechanicsLaurence W. Grossman, Ph.D.301-796-2502
Deputy DirectorJon Casamento301-796-2499
Division of Chemistry and Materials ScienceDinesh Patwardhan, Ph.D.301-796-2622
Deputy DirectorBenita Dair, Ph.D.301-796-2614
Division of Imaging and Applied MathematicsKyle Myers, Ph.D.301-796-2533
Deputy DirectorNicolas Petrick, Ph.D.301-796-2563
Division of Electrical and Software EngineeringAlford Taylor, Jr.301-796-2583
Deputy DirectorBrian Fitzgerald301-796-2579
Office of Communication and Education
Director:Lynne L. Rice301-796-5660
Deputy DirectorHeather D. Howell301-796-5718
Associate Director for Internal CommunicationsJoyce Siwarski301-796-5422
Associate Director for Outreach and ReviewMark H. Barnett240-276-3970
Associate Director for Program OperationsClifford D. Evans301-796-6644
Special Assistant to the DirectorSharon Davis301-796-5717
Special Assistant to the Deputy DirectorSuzette Mocreia301-796-5368
Digital Communication Media Staff (Formerly Division of Communication Media)Chad Heupel240-276-0922
Division of Employee Training and Development (Formerly Staff College)Jacqueline Woodard301-796-5670
Deputy DirectorLaura Stewart301-796-5673
Division of Health CommunicationLaurel S. Mendelson301-796-5764
Deputy DirectorKristine Butler301-796-5843
Strategic Communication BranchAlicia Witters301-796-5846
Web Communication BranchEdie Seligson301-796-5768
Division of Industry and Consumer Education (Formerly Division of Small Manufacturers, International and Consumer Assistance)Elias Mallis301-796-6216
Deputy DirectorWilliam Sutton301-796-5849
Postmarket and Consumer BranchJoseph Tartal301-796-5853
Premarket Programs BranchXiaoqiu Tang301-796-5850
Division of Information Disclosure (Formerly the Division of Freedom of Information)Bill Holzerland301-796-5897
Deputy DirectorCandace Boston240-402-3736
Freedom of Information Branch ALatroy Tinch301-796-5952
Freedom of Information Branch BAnastazia Taylor240-402-3737