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

Medical Device Premarket Approval and Postmarket Inspections - Attachment: B

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CP 7383.001 ATTACHMENT B

CDRH Office of Compliance Organizational Chart

Office of the Director:

Steven D. Silverman, Director
David Kalins, Acting Deputy Director of Regulatory Affairs
Kimber C. Richter, Deputy Director of Medical Affairs
Crystal King, Strategic Planning/Organizational Development
Dave Kalins, Field Liason
Bryan Benesch, Special Assistant
Scott McNamee, Special Assistant
(301) 796 5500; Fax: (301) 847 8136

  • Import/Export Staff
    David Kalins, Acting Deputy Director of Regulatory Affairs
    (301) 796 5500; Fax: (301) 847 8136

  • Quality Systems Team
    David Kalins, Acting Deputy Director of Regulatory Affairs
    (301) 796 5500; Fax: (301) 847 8136

  • Promotions and Advertisement
    Deborah Wolf, Regulatory Counsel
    (301) 796 5500; Fax: (301) 847 8136

  • Program Management Staff
    Carolyn Bell, Program Management Officer
    (301) 796 5500; Fax: (301) 847 8136

  • Quality Management Staff
    Frances Benedict, Director, Quality Management Systems
    (301) 796 5500; Fax: (301) 847 8136

  • Division of Enforcement A
    Anastacia Bilek, Director
    George Kroehling, Deputy Director
    (301) 796 5770; Fax: (301) 847 8137

    • General Hospital Devices Branch
      Debra Demeritt, Acting Branch Chief
      (301) 796 5770; Fax: (301) 874 8137

    • Ob/Gyn, Gastro and Urology Devices Branch
      Paul Tilton, Branch Chief
      (301) 796 5770; Fax: (301) 847 8137

    • Dental, ENT and Ophthalmic Devices Branch
      Ron Swann, Branch Chief
      (301) 796 5770; Fax: (301) 847 8137

    • General Surgery Devices Branch
      LaShanda Long, Branch Chief
      (301) 796 5770; Fax: (301) 847 8137

  • Division of Risk Management Operations
    Ann Ferriter, Director
    John Murray, Acting Deputy Director
    (301) 796 5530; Fax: (301) 847 8128

    • Regulatory Policy and Systems Branch
      Leila Lawrence, Acting Branch Chief
      (301) 796 5530; Fax: (301) 847 8128
      For Registration and Listing
      (301) 796 7400

    • Field Programs Branch
      Thomas Slater Jr., Acting Branch Chief
      (301) 796 5530; Fax: (301) 847 8128

    • Recall Branch
      Hany Demian, Acting Branch Chief
      (301) 796 5530; Fax: (301) 847 8128

  • Division of Bioresearch Monitoring
    Jim Salviola, Director
    Matthew J. Tarosky, Deputy Director
    (301) 796 5490; Fax: (301) 847 8136

    • Special Investigations Branch
      Ann Hawthorn, Branch Chief
      (301) 796 5490; Fax: (301) 847 8136

    • Program Enforcement Branch A
      Linda Godfrey, Branch Chief
      (301) 796 5490; Fax: (301) 847 8136

    • Program Enforcement Branch B
      Kathy Weil, Branch Chief
      (301) 796 5490; Fax: (301) 847 8136

  • Division of Enforcement B
    Bill MacFarland, Director
    Valerie Flournoy, Deputy Director
    (301) 796 5540; Fax: (301) 847 8138

    • Cardiac Rhythm and Electrophysiology Devices Branch
      Joshua Simms, Branch Chief
      (301) 796 5540; Fax: (301) 847 8138

    • Vascular and Circulatory Support Devices Branch
      Daniel Walter, Branch Chief
      (301) 796 5540; Fax: (301) 847 8138

    • Orthopedics and Physical Medicine Devices Branch
      Matthew Krueger, Branch Chief
      (301) 796 5540; Fax: (301) 847 8138

    • Radiology, Anethesiology and Neurological Devices Branch
      Charles Cathlin, Branch Chief
      (301) 796 5540; Fax: (301) 847 8138

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