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U.S. Department of Health and Human Services

About FDA

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Laboratory of Toxicology and Biocompatibility

Laboratory leader: Peter Goering 301.796.0253 peter.goering@fda.hhs.gov

The Laboratory of Toxicology and Biocompatibility is located in the Division of Biology and is an interconnected program of laboratory research, risk assessment, and guidance/standards development activities designed to promote a scientific basis for regulatory decision making in CDRH.  The primary goal of the Laboratory is the development of research approaches and methodologies to improve the safety evaluation of materials used in medical devices or compounds released from medical devices.  Potential adverse effects of medical device materials and chemicals are evaluated using various biological experimental models, as well as computational modeling approaches.  Data generated in the Laboratory are used to help understand the risks facing patients exposed to medical device materials or compounds released from the materials, to support risk management decision-making in the Center, and ultimately protect the health of the public. 

To address this goal, the Laboratory currently focuses on the following areas:  

Nanotechnology: The use and incorporation of nanotechnology is rapidly evolving with many new medical and consumer applications.  Because of their ultra-small size and other unique properties, nanoscale materials and structures can impart desirable characteristics to medical devices, and have been used in bone void fillers, dental resins, and antimicrobial coatings on wound dressings and catheters.  Other FDA-regulated products expected to utilize nanotechnology include: implants and prosthetics, sensors for disease diagnosis, drug delivery therapeutics, and medical imaging enhancers.  The presence of nanoscale materials may affect the safety of a device.  It is not yet determined whether nanoscale materials should be treated as “new chemical entities” and therefore will require additional test methods to evaluate their safety.  Projects are underway in this Laboratory to address the biodistribution (where do the materials go in the body and how long do they stay there?) and potential adverse effects (which organs or cell types are injured?) of nanoscale materials.

Risk Assessment: The Laboratory is charged with addressing high profile risk assessment issues facing the center.  Projects in this area are directed toward providing missing information that would improve our understanding of risks to patients who are exposed to compounds released from medical device materials.  The Laboratory is also involved in developing novel approaches for assessing the risk posed by patient exposure to compounds released from devices, consistent with the vision articulated by the FDA Critical Path Initiative and by the National Academy of Sciences in their report, Toxicity Testing in the 21st Century. 

Biocompatibility: Medical devices typically undergo a battery to safety tests before being cleared by FDA for marketing.  Among these are tests to evaluate the biological safety, or biocompatibility, of the device.  Guidance on how to conduct these tests is provided in standards developed by the U.S. or international consensus standards bodies.  The goal of the Laboratory’s projects is to improve the test methods used to assess the biocompatibility of medical devices by making them more relevant to the clinical patient situation and conditions.  The results of these studies will allow review scientists in CDRH to make better decisions about the biological safety of medical devices.

 


Lab staff work to improve the clinical relevance of biocompatibility test methods.