DBCMS.JPG

Stent

A scientist working with test tubes.

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

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