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CDRH Organization Structure
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This information is current as of 9/21/04

CDRH Organization Chart

Office of the Center Director Office of Surveillance and Biometrics
Office of Communication, Education, and Radiation Programs
(Formerly OHIP)		 Office of Management Operations
(Formerly OSM)
Office of Compliance CDRH Facility Locations
Office of Device Evaluation CDRH Referral List
Office of In Vitro Diagnostic Device Evaluation
and Safety
Staff Directory Search
Office of Science and Engineering Laboratories
(Formerly OST)		  

Office of the Center Director

Center Director
Daniel Schultz, M.D.
301-827-7975

Deputy Director
Linda S. Kahan
301-827-7975

Senior Associate Director
Lillian J. Gill
301-827-7975

Associate Director for Management and Systems
Ruth E. McKee
301-827-7663

CIO's Office of Information Technology CDRH
Stu Carlow
301-594-4550 X132

Assistant Director for Education and Communication
Mark H. Barnett
301-827-7982

Executive Services
Lily Ng
301-827-7975

Clinical Deputy Director
Binita Ashar
301-594-1307 X137

Ombudsman/Quality Assurance Manager
Les Weinstein
301-827-7991

Assistant Director for Strategic Planning
Robert Navazio
301-827-7975

Director, CDRH Medical Device Fellowship Program
Susan Homire
301-827-2890

Office of Management Operations

Director
Ruth E. McKee
301-827-7663

Associate Director for Management
Sandy Cordes
301-827-7663

White Oak Planning Coordinator
Frank Benedetti
301-827-4728

Program Management Officer
Debra Baclawski
301-827-5575 114

Division of Ethics and Management Operations
Sandy Roderick-Rudden
301-827-4516

Deputy Director
M. Shannon Gipson
301-827-0843

Occupational Health and Safety Officer
Tom Vegella
301-827-0346

Administrative Management Branch
Debra Grygier, Acting
301-827-9482

Integrity, Conference and Committee Management Branch
Kathleen Walker
301-594-1283 X114

Freedom of Information Branch
Joy Lazaroff, Acting
301-594-4774 X128

Div of Planning, Analysis & Finance
Patric Baumgartner
301-594-1282 X117

Planning Branch
Marjorie Waskewich
301-594-1905 119

Analysis Branch
Bonnie Markovitz
301-594-1284 126

Financial Management Branch
Tracy Hill
301-594-3006 161

Office of Compliance

Director
Timothy A. Ulatowski
240-276-0100

Deputy Director for Regulatory Affairs
Larry Spears
240-276-0100

Deputy Director for Medical Affairs
Kimber Richter
240-276-0105

Special Assistant
Casper Uldriks
240-276-0100

Assistant to the Director
Harold Pellerite
240-276-0100

Promotion and Advertising Policy Staff
Harold Pellerite, Acting
240-276-0100

Division of Program Operations
Karen L. Moss
240-276-0130

Deputy Director
Vacant
240-276-0130

Field Programs Branch
Allen Wynn
240-276-0130

Information Processing and OA Branch
Scott Lowe
240-276-0130

Registration & Listing Forms
240-276-0110

Division of Bioresearch Monitoring
Michael Marcarelli
240-276-0125

Program Enforcement Branch
Viola Sellman
240-276-0125

Special Investigations Branch
Vacant
240-276-0125

Division of Enforcement A
Betty W. Collins
240-276-0115

Deputy Director
George Kroehling
240-276-0115

Dental, ENT and Ophthalmic Devices Branch
Ronald L. Swann
240-276-0115

OB/GYN, Gastro. & Urology Devices Branch
Paul Tilton
240-276-0115

General Hospital Devices Branch
Carolyn Niebauer
240-276-0115

General Surgery Devices Branch
Thomas Knott
240-276-0115

Division of Enforcement B
Gladys Rodriquez
240-276-0120

Deputy Director
Christy Foreman
240-276-0120

Cardiovascular & Neurological Devices Branch
Don Serra
240-276-0120

Diagnostic X-ray Devices Branch
Thomas M. Jakub
240-276-0120

Electronic Products Devices Branch
Sean Boyd, Acting
240-276-0120

Orthopedic, Physical Medicine & Anesthesiology Devices Branch
William MacFarland
240-276-0120

Office of Device Evaluation

Director, Acting
Donna Bea Tillman, Ph.D.
301-594-2022

Deputy Director for Science and Regulatory Policy
Philip J. Phillips
301-594-2022

Deputy Director for Technology and Review Policy
Donna Bea Tillman, Ph.D.
301-594-2022

Deputy Director for Clinical
Aron Yustein, M.D., Acting
301-594-2022

Integrity Officer
Carl T. DeMarco, R.Ph., J.D.
301-594-2022

Advisory Panel Coordinator
Nancy J. Pluhowski
301-594-2022

Program Management Office
Kathryn K. Appler
301-594-3055

Management Services Section
Sharyn A. Dowtin
301-594-3055

Program Operations Staff
Robert Gatling
301-594-1190

Premarket Approval Section
Thinh X. Nguyen
301-594-2186

Investigational Device Exemption Section
Elisa Harvey, DVM, Ph. D., Acting
301-594-1190

Premarket Notification Section
Heather S. Rosecrans
301-594-1190

Division of General, Restorative and Neurological Devices
Celia M. Witten, Ph.D., M.D.
301-594-1184

Deputy Director I
Mark N. Melkerson
301-594-1184

Deputy Director II
Miriam Provost, Ph.D.
301-594-1184

Plastic & Reconstructive Surgery Devices Branch
Stephen Rhodes
301-594-3090

General Surgery Devices Branch
Neil R. Ogden
301-443-1307

Orthopedic Devices Branch
John Holden, Ph.D., Acting
301-594-2036

Restorative Devices Branch
Theodore Stevens
301-594-1296

Division of Cardiovascular Devices
Bram D. Zuckerman, M.D.
301-443-8320

Deputy Director I
Donna Lochner
301-443-8320

Deputy Director II
Barbara Zimmerman, Acting
301-443-8320

Associate Director for Guidance and Policy
Arthur A. Ciarkowski
301-443-8320

Associate Director for Clinical Trials
Wolf Sapirstein, M.D
301-443-8320

Pacing, Defibrillator and Leads Branch
Megan Moynahan
301-443-8517

Cardiac Electrophysiology & Monitoring Devices Branch
Elias Mallis
301-443-8517

Interventional Cardiology Devices Branch
Ashley Boam
301-443-8243

Circulatory Support and Prosthetic Devices Branch
Dina Fleischer
301-443-8517

Peripheral Vascular Devices Branch
A. Doyle Gantt, Acting
301-443-8320

Division of Ophthalmic and ENT Devices
A. Ralph Rosenthal, M.D.
301-594-2205

Deputy Director
David M. Whipple
301-594-2205

Vitreoretinal & Extraocular Devices Branch
James Saviola, O.D.
301-594-1744

Intraocular and Corneal Implants Branch
Kesia Alexander, Acting
301-594-2053

Diagnostic and Surgical Devices Branch
Everette T. Beers, Ph.D.
301-594-2018

Ear, Nose, and Throat Devices Branch
Eric A. Mann, M.D., Ph.D.
301-594-2080

Division of Reproductive, Abdominal, and Radiological Devices
Nancy C. Brogdon
301-594-5072

Deputy Director
David A. Segerson
301-594-5072

Obstetrics/Gynecology Devices Branch
Colin M. Pollard
301-594-1180

Urology and Lithrotripsy Devices Branch
Janine Morris
301-594-2194

Gastroenterology and Renal Devices Branch
Carolyn Neuland, Ph.D.
301-594-1220

Radiological Devices Branch
Robert A. Phillips, Ph.D.
301-594-1212

Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices
Chiu S. Lin, Ph.D.
301-443-8879

Deputy Director
M. Susan Runner, D.D.S.
301-827-5283

Infection Control Devices Branch
Kevin Mulry, Acting
301-827-5283

Dental Devices Branch
M. Susan Runner, D.D.S.
301-827-5283

General Hospital Devices Branch
Anthony D. Watson
301-594-1287

Anesthesiology and Respiratory Devices Branch
Ann Graham, Acting
301-827-4479

Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Director
Steven I. Gutman, M.D.
301-594-3084 154

Deputy Director, New Product Evaluation
Donald J. St. Pierre
301-594-3084 175

Deputy Director, Patient Safety and Product Quality
James L. Woods
301-594-3084 177

Program Management Officer
David R. Warren
301-594-3084 165

Division of Chemistry and Toxicology Devices
Jean Cooper, D.V.M.
301-594-1243 153

Division of Immunology and Hematology Devices
Robert L. Becker, M.D.
301-594-1293 212

Division of Microbiology Devices
Sally A. Hojvat, Ph.D.
301-594-2096 114

Office of Surveillance and Biometrics

Director
Susan N. Gardner, Ph.D.
301-594-2812

Deputy Director
Stephen M. Sykes
301-594-2812

Issues Management Staff
Patricia Kingsley, Director
301-594-2784

Program Management Office
Donna Schwartz
301-594-1254

Division of Postmarket Surveillance
Thomas P. Gross, M.D.
301-594-1144

Deputy Director
Steven Chasin, Ph.D.
301-594-3674

Product Evaluation Branch I
Suzanne E. Rich
301-594-2581

Product Evaluation Branch II
Sonia Swayze
301-594-2102

Epidemiology Branch
Hesha Jani Duggirala, Ph.D., Acting
301-594-0603

Division Surveillance Systems
David S. Shindell, Ph.D.
301-827-7535

Deputy Director
Mary Weick Brady
301-827-7535

Systems Support Branch
Indira Konduri
301-827-0023

Reporting Systems Monitoring Branch
Sharon Kapsch
301-594-3380

Information Analysis Branch
Howard Press
301-827-2983

Division of Biostatistics
Greg Campbell, Ph.D.
301-594-0616

Deputy Director
Kay Barrick
301-594-0616

Office of Science and Engineering Laboratories (Formerly OST)

Director
Larry Kessler, Sc.D.
301-827-4777

Deputy Director
William A. Herman
301-827-5599

Deputy Director
Subhas G. Malghan, Ph.D.
301-827-4777

Special Assistant to the Director
Thomas Lee.
301-443-2536

Assistant Director for Laboratory Coordination
Judith A. Kalson
301-443 4777

Director, Standards Management Staff
Carol Herman
301-594-4766 X137

Director, Management Support Services
Angie Clingerman
301-827-4727

Division of Biologics
Marilyn M. Lightfoote, M.D.
301-443-2936

Deputy Director
Melvin E. Stratmeyer, Ph.D., Acting
301-443-7130

Deputy Director
John J. Langone, Ph.D., Acting
301-443-7132

Division of Physics
Robert H. James, Acting
301-827-4678

Deputy Director
Brian Beard, Acting
301-827-4958

Division of Solid and Fluid Mechanics
Laurance W. Grossman, Ph.D.
301-827-5611

Deputy Director
Jon Casamento, Acting
301-827-4959

Division of Chemistry and Materials Science
Subhas G. Malghan, Ph.D., Acting
301-827-4777

Deputy Director
Kaiser Aziz
301-443-7166

Division of Imaging and Applied Mathematics
David G. Brown, Ph. D.
301-443-3314 X140

Deputy Director
Thomas Shope, Acting
301-443-3314 X132

Division of Electrical and Software Engineering
Alfred Taylor, Jr. Acting
301-443-2536

Deputy Director
Brian Fitzgerald, Acting
301-443-2536

Office of Communication, Education, and Radiation Programs (Formerly OHIP)

Director
Lynne L. Rice
301-443-2845

Deputy Director
John McCrohan
301-443-2845

Assistant Director for Program Operations
Clifford D. Evans
301-594-2384

Special Assistant to the Director
Heather D. Howell
301-594-3263

Director, Staff College
Renee A. Brotman
301-827-3560

Regulations Staff
Joseph M. Sheehan
301-594-4765

CDRH Internet Staff
301-594-3533

Division of Device User Programs and Systems Analysis
Cornelia B. Rooks
301-443-2436

Deputy Director
Margaret T. Tolbert
301-443-2436

Associate Director
Jay A. Rachlin
301-443-2436

Human Factors Engineering Branch
Robert J. Cangelosi
301-594-2683

Outreach and Public Participation Branch
Alvin W. Thomas
301-443-2436

Division of Small Manufacturers, International and Consumer Assistance
John F. Stigi
301-443 6597 124

Deputy Director
William M.Sutton
301-443-6597 125

Technical Assistance Branch
Joseph V. Puleo
301-443-6597 116

Regulatory Assistance Branch
Thomas E. Cardamone
301-443-6597 115

International Relations and External Affairs Staff
M. Christine Nelson
301-443-6597 128

Division of Communication Media
Robert F. McCleary
301-827-3555

Television Design and Development Branch
Vacant
301-827-3555

Division of Mammography Quality and Radiation Programs
Director
Helen J. Barr, M.D.
301-594-3332

Deputy Director, Acting
CAPT Thomas R. Ohlhaber
301-594-3332

Associate Director for Policy and Clinical Affairs
Charles A. Finder M.D.
301-594-0009

Associate Director for Operations
Kathleen M. Sheridan
301-594-3275

Accreditation and Certification Branch
Kathleen A. Franke
301-594-2787

Radiation Programs Branch, Acting
Petro Shandruk
301-594-3533

Information Management Branch
Timothy J. Haran
301-594-3308

Inspection and Compliance Branch, Acting
Michael P. Divine
301-594-3534

Electronic Product Devices Branch, Acting
LCDR Sean Boyd
240-276-0161

Diagnostic Devices Branch
CAPT Thomas Jakub
240-276-0120

Updated November 3, 2004

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