A Risk-Based Approach to Medical Device Testing Starts with Extractables and Leachables

As industry and regulatory bodies adopt the ISO 10993 Risk-Based Approach to Biological Evaluations, the demand for materials characterization studies increases.

And just as materials characterization plays a role in device design and development, extractables and leachables studies play a role in regulatory submission and preclinical safety testing.

WuXi AppTec works with you to first determine the best analytical approach for your medical device. We help you determine testing parameters, based on the device’s classification and indication for use (such as the intended population, route of administration and clinical application).

Once an extractables and leachables study is determined to be appropriate for a device, WuXi offers you an industry-leading analytical chemistry department and access to our toxicologists for consultation, regulatory guidance and toxicological risk assessments.

We understand the complexity of the analytical chemistry and the identification of compounds. Chemistry data derived from thorough extractables and leachables studies supplies a toxicologist with the chemicals for a risk assessment. The chemistry data is also a pool of data that a toxicologist may use as support evidence of risk mitigation in the event of a color change or particulate present within a biocompatibility extract. In addition, a regulatory trend (most commonly with blood-contacting, permanent implants) is exhaustive extractions. This is scientifically complicated, and increases the complexity of identification within the extractables study.

Our extractables and leachables program has conducted more than 4500 projects, and our commitment to complete chemical characterization makes our program stand out. In fact, we built our program on complete identification since that is essential to evaluating the toxicological risk.

For more information on our extractables and leachables testing, contact us at 888.794.0077.