SMG 1254.4

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 CHEMISTRY AND MATERIALS SCIENCES

Effective Date: 07/08/2011

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1. DIVISION OF CHEMISTRY AND MATERIALS SCIENCES (DKKWEA)

A. Participates in the Center's mission in a variety of ways including conducting 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 chemistry and materials sciences

B. Focus on the development of experimental data, test methods and protocols for regulatory and scientific activities involving multicomponent mass transfer, reaction kinetics, absorption and swelling of network polymers, polymer processing, modeling of physiological processes, and materials degradation

C. Research conducted includes polymer synthesis; synthesis of polymeric nanocomposite materials; sensors; thermodynamics; thermal transitions and phase stability; hydrogel and biopolymer synthesis and characterization; polymer formulation; separations; spectroscopy; small-angle x-ray and neutron scattering; and shelf-life and service life prediction

D. Tests the performance of chemical processes of importance to medical devices, such as mass transfer through membranes used in dialysis, and blood oxygenation, and manufacturing processes used to fabricate materials

E. The technical disciplines include physical chemistry, chemical physics, polymer science, pharmacology, materials science, and biomedical and chemical engineering

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