SMG 1254.1

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF MEDICAL PRODUCTS AND TOBACCO

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

OFFICE OF SCIENCE AND ENGINEERING LABORATORIES

Effective Date: 07/08/2011

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1. OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (DKKWE)

A. Provides scientific support and laboratory analyses in response to the program needs of other Center and Agency components

B. Plans, develops, and implements an intramural science program covering key areas of engineering, physics, and biology; develops, modifies, and validates test methods and measurement techniques, risk assessments and hazard analyses, and generic techniques to enhance product safety and usefulness

C. Provides scientific and engineering support in the review of regulatory documents, the development of regulatory decisions, and the analysis of postmarket surveillance issues

D. Plans, conducts, or stimulates research on the human health effects of radiation and medical devices

E. Participates in the development of national and international consensus standards and voluntary guidelines through interaction with appropriate standards committees; coordinates with other standards-setting groups representing national and international standards-setting organizations; conducts the review and analysis of performance standards, guides and documents related to the Center's mission

F. Establishes official liaisons with Standards Development Organizations. Coordinates the liaison within the Center. Establishes and maintains records on committee participation and status of medical device standards used by the Center

2. MANAGEMENT SUPPORT STAFF (DKKWE1)

A. Provides leadership and support to the Office of the Director, Division Directors and laboratory professionals on all administrative and management issues

B. Responsible for planning, developing, and implementing Center and OSEL programmatic matters concerning financial management, personnel, procurement, contracts, inter-agency agreements, employee training, and facilities

C. Tasked with the management and administration of OSEL resources designed to support ongoing programs

D. Ensures proper distribution of operating and payroll dollars, facility plans, procurement and property, travel requests and ADP needs

E. Advises the Office of the Director on potential issues that may affect resources, staffing, and management issues to comply with policies and avoid potential conflicts

F. Directs and conducts special assignments or projects for the Center as well as the Office Director

3. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Office were approved by the Secretary of the Department of Health and Human Services on July 8, 2011.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	02/19/2004	N/a	OC/OO/ OM/OMP	Center Director, CDRH
Revision	06/10/2011	N/a	CDRH/OMO	Director, Center for Devices and Radiological Health
Revision	07/08/2011	N/a	CDRH/OMO	Secretary of Health and Human Services