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CDRH-OIVDDES Organization Chart

The following header reflects the organizational hierarchy.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
OFFICE OF IN VITRO DIAGNOSTIC DEVICE EVALUATION AND SAFETY

The following is the communication box containing information to assist anyone who may want to communicate with the depicted organization via telephone, facsimile or mail.

Main telephone: 240-276-0484 x154
Fax: 240-276-0652
Address:
Room 261, Bldg OAK8
2098 Gaither Road
Rockville, MD 20850
Mail Code: HFZ-440

The following is the Food and Drug Administration’s, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety organization structure depicting all the organizational structures reporting to the Office Director. These organizational structures are organized in sequential order by their assigned Standard Administrative code (Alphanumeric sequence of characters beginning with the letter D).

Each organizational component will be depicted in the following standard format:

Title of organization.
Position title of the manager.
Military rank if any, first name, middle initial if any, last name, post graduate degrees if any, and if the individual is designated as acting.
Standard Administrative code.

OFFICE OF THE DIRECTOR
DIRECTOR
Steven I. Gutman, M.D.

DEPUTY DIRECTOR FOR NEW PRODUCT EVALUATION
Alberto Gutierrez, Ph.D.

DEPUTY DIRECTOR FOR PATIENT SAFETY AND PRODUCT QUALITY
James L. Woods

ASSOCIATE DIRECTOR FOR POLICY AND OPERATIONS
Donald St. Pierre

PROGRAM MANAGEMENT OFFICER
David R. Warren
(DBWJ)

DIVISION OF CHEMISTRY AND TOXICOLOGY DEVICES
DIRECTOR
Jean M. Cooper, D.V.M.
(DBWJA)

DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES
DIRECTOR
Maria M. Chan, Ph.D. (Acting)
(DBWJB)

DIVISION OF MICROBIOLOGY DEVICES
DIRECTOR
Sally A. Hojvat, Ph.D.
(DBWJC)

Prepared by the Office of Management Programs, OM - 10/22/08

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