WHAT: Part of  Office of Science and Engineering Laboratories (OSEL), CDRH

WHY:

• Determine effects of implanted devices, potential device adverse effects,  source and impact of device degradation
• Develop experimental data, test methods, and protocols
• Develop measurements, methods, and analytical procedures to support CDRH pre-market and post-market activities.

WHO: Experts in biology, biomaterials science, biomedical and chemical engineering, chemical physics, materials science, pharmacology, physical chemistry, polymer science, and toxicology

HOW: Focus on

• analytical chemistry and electrochemistry
• biocompatibility, toxicology, and biological risk assessment
• biosensors and biomarkers
• extractables, leachables, and chemical contamination
• genomic and genetic technologies
• immune and cellular responses
• infection control, sterility, and biofilms
• materials characterization, processing, and materials degradation
• modeling of physiological processes
• multicomponent mass transfer and reaction kinetics
• nanotechnology