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  5. Medical Device Premarket Approval and Postmarket Inspections - Attachment: C
  1. Quality and Compliance (Medical Devices)

Medical Device Premarket Approval and Postmarket Inspections - Attachment: C

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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


  • 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


  • 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


  • 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


  • 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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