SMG 1254.3

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

DIVISION OF BIOLOGY

Effective Date: 07/08/2011

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1. DIVISION OF BIOLOGY (DKKWEB)

A. Conducts research, participating in device review activities, developing consensus standards both domestic and international, developing regulatory guidance, testing forensic and regulatory samples, and providing educational programs in the area of biological sciences

B. Conducts research to support the Center's mission to assure the safety and effectiveness and promote the improvement of medical devices in the areas of biological risk assessment, biosensors/nanotechnology, genomic and genetic technologies, infection control and sterility, tissue-device interactions, toxicity/biocompatibility, and radiation bioeffects

C. Through laboratory studies, evaluate the potential adverse effects of medical devices on host biological systems and in collaboration with engineering divisions, identify the source and impact of product degradation on organ systems both under acute and chronic conditions

D. Develops measurements methods and analytical procedures to characterize and evaluate devices and products, studies molecular and cellular mechanisms and bioeffects of biomaterials, and supports the Center's enforcement and product testing activities

E. Staff members are primarily biologists, chemists, and biomaterials scientists

2. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Division 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	07/08/2011	N/a	CDRH/OMO	Secretary of Health and Human Services