About FDA

Division of Biology, Chemistry, and Materials Science

Email: OSEL-DBCMS@fda.hhs.gov

The Division of Biology, Chemistry, and Materials Science (DBCMS) participates in the Center's mission of protecting and promoting public health by identifying and investigating issues related to the interaction between medical devices and the human body. The division accomplishes this through activities supporting the OSEL mission.

Stent A scientist working with test tubes.

Some examples of research by DBCMS include determining whether an implanted device will be compatible in the body, including computational techniques to assess the release of potentially harmful substances; assessing the effects of materials, structure, chemistry, and manufacturing on medical devices; understanding how device materials and design can affect the development of healthcare-associated infections; and determining potential sources for contamination and adulteration of materials used in devices. These serve the Center’s mission of advancing regulatory science, facilitating consistent and efficient regulatory pathways, and assuring continued access to safe, effective, and high-quality medical devices.

Specifically, DBCMS focuses on device issues that involve:

  • 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; and
  • nanotechnology.

DBCMS has expertise evaluating the effects of human biology on implanted devices and the potential adverse effects of devices on the human body as well as identifying the source and impact of device degradation on human organ systems. In addition, DBCMS develops measurements, methods, and analytical procedures to characterize and evaluate devices and products, studying the molecular and cellular mechanisms and the bioeffects of biomaterials, to support the Center’s pre-market and post-market activities.

DBCMS also develops experimental data, test methods, and protocols for multicomponent mass transfer, reaction kinetics, absorption and swelling of network polymers, and polymer processing as well as the modeling of physiological processes and materials degradation. DBCMS tests chemical processes important to medical devices, such as the diffusion of small molecules through the material of a medical device. This includes oxygen transport and cardiac therapies such as blood oxygenation, dialysis, and the release of toxicants.

The technical disciplines of DBCMS staff include biology, biomaterials science, biomedical and chemical engineering, chemical physics, materials science, pharmacology, physical chemistry, polymer science, and toxicology.
 

Page Last Updated: 03/17/2015
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