Medical Device Premarket Approval and Postmarket Inspections - Attachment: C

CP 7383.001 ATTACHMENT C

CDRH Office of In Vitro Diagonostic Devices Organizational Chart

Office of the Director

Alberto Gutierrez, Director
Christine Kellerman, Secretary

Personalized Medicine Staff
Elizabeth Mansfield, Deputy Director
Marina Kondratovich, AD for Clinical Studies
Zivan Tezak-Fragale, AD for Science and Technology

New Product Evaluation
Donald St. Pierre, Deputy Director
Robert Becker, Chief Medical Officer
David Brown, Acting AD for Policy and Operations
Jean Cooper, AD for Surveillance and Outreach Programs
Naziha Hanna
Renita Hoard
Scott McFarland
David Warren, Program Management Officer
Kelly Wilkicki

Patient Safety and Product Quality
James Woods, Deputy Director
Rebecca Keenan
Tonya Wilbon

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• Division of Chemistry and Toxicology Devices (DCTD)
  Courtney Harper, Director
  Latricia Dickson-Scott
  Donna Bush
  Janne Cummings
  Ileana Elder
  Tan Nguyen
  Jacqueline Wieneke

  • Chemistry Team
    Carol Benson, Associate Director
    Patricia Bernhardt
    Erich Boger
    James Callaghan
    Paula Caposino
    Yung Chan
    Ann Chappie
    Ruth Chesler
    Jennifer Fitch
    Leslie Landree
    Shirin Marfatia
    Vicki Moyer
    Elizabeth O'Keeffe
    Ian Pilcher

  • Toxicology Team
    Zhihao (Peter) Qiu, Associate Director
    Avis Danishefsky
    Denise Johnson-Lyles
    Kellie Kelm
    Jinong Li
    Nadezda Radoja
    Arleen Pinkos
    Katherine Serrano
    Stayce Beck
    Douglas Rheinheimer
    Juandria Williams

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• Division of Immunology and Hematology Devices (DIHD)
  Maria Chan, Director
  Gretchen Kindle
  Joshua Levin
  Gerald Marti
  Joan McClain-Bennet
  Max Robinowitz
  

  • Immunology Team
    Reena Philip, Associate Director
    Karen Bijwaard
    Therese Datiles
    Nina Hunter
    Carolina Kagan
    Kevin Lorick
    Ying Mao
    Nisar Pampori
    Edappallat Radha
    Lakshman Ramamurthy
    James Reeves
    Donna Roscoe
    Timothy Schaefer
    Elizabeth Stafford
    Abraham Tzou

  • Hematology/Pathology Team
    Leonthena Carrington, Associate Director
    Nick Anderson
    Brenda Bell
    Ronny Brown
    Janine Bey
    Christopher Duncan
    Tremel Faison
    Valerie Ginyard
    Caryl Giuliano
    Yun-Fu Hu
    Shyam Kalavar
    Kevin Maher
    Jeb Monasterial
    Lan Nguyen
    Kennita Riddick
    Paula Stewart
    Daniella Turley
    Tena Wei

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• Division of Microbiology Devices
  Sally Hojvat, Director
  Carletta Moore, Secretary
  Dainelle Clark
  Natalia Comella
  Sahar Dawisha
  Claudia Gaffey
  Steven Gitterman, Medical Speciality Team Lead
  Tara Goldman
  Krishna Ghosh
  Victoria Scharf
  Yvonne Shea

  • Bacteriology Team
    Freddie Poole, Associate Director
    Alison Cotterell
    Andrew Grove
    Marian Heyliger
    Raquel Peat
    Kimberly Sconce
    Ribhi Shawar
    Janice Washington
    Michael White
    Michael Wiack
    Alexandra Wong

  • Virology Team
    Uwe Scherf, Associate Director
    Stefanie Akselrod
    Haja Sittana El Mubarak
    Tamara Feldblyum
    John Hobson
    Li Li
    M Luo
    Francisco Martinez-Murillo
    Beena Puri
    Kathleen Simon
    William Shackleford
    Peter Summers
    Kathleen Whitaker
    Ruo Xu

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• Division of Radiological Devices
  Mary Pastel, Director
  Michael O'Hara, Deputy Director
  John Chen
  Ewa Czerska
  Jana Delfino
  Paul Hardy
  Lauren Hefner
  Kimberly Howell
  William Jung
  Simkson Kang
  Robert Ochs
  Brendan O'Leary
  Jay Vaishnav
  Shahram Vaezy
  Nancy Wersto

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