By Matthew R. Jorgensen, PhD
Published: MD+DI online
Extractable/leachable chemistry testing can save, time, money, and animal life for certain classes of devices. Over the past decade, regulatory bodies have shifted their evaluation of biocompatibility from a strict linear approach to a less linear approach that includes in vitro tests and assessment using chemistry. Chemistry has the advantage of providing detailed information on the identity and amount of substances that can leave devices, while traditional biocompatibility tests are pass or fail. The challenge with chemistry can be that a deeper understanding of device materials and the science of extractable/leachable testing is required to correctly interpret results. Fortunately, for those companies without expertise in using chemistry to fulfill regulatory requirements, help is available through consulting services. The following are three frequently asked questions when consulting on these matters.