Medical Device and Combination Product Specialty Section

The medical device industry is a rapidly growing, $500 billion dollar enterprise that produces a diverse range of products. The role of toxicologists in the evaluation of medical devices is evolving in response to a number of factors, including changing regulatory paradigms, use of novel materials, development of combination products, and increased public concern about potential exposure to medical device chemical components. The Medical Device and Combination Product Specialty Section (MDCPSS) was formed in Fall of 2009, with the purpose of providing an international forum where government, industry, and academic toxicologists can share state-of-the-art knowledge and develop new approaches for the evaluation of medical devices.

Our members are a dynamic mix of scientists from device manufacturing companies, CROs, regulatory agencies, and consulting companies; we are actively seeking members among academic faculty and students. Our specific areas of interest include: plastics, metals, ceramics, materials of biologic origin, and validation of new/alternative toxicology assays for medical devices.

The objectives of the MDCPSS are:

1. Provide an international focus group for toxicologists working in the area of medical devices and combination products including a device component
2. Promote the development of new experimental methods for the evaluation of medical devices
3. Sponsor scientific and educational programs that emphasize current developments and issues in the toxicological evaluation of medical devices
4. Promote proactive communication and interactions among toxicologists in government regulatory agencies, regulated industry, and academia regarding current issues in medical device toxicology
5. Stimulate interest in medical device safety as a career path for new toxicologists