A biological evaluation is a weight of evidence. It consists of materials characterization – approached through extractables and leachables studies; toxicological risk assessment, and biocompatibility – to address local and systemic endpoints. Initially, extractables and leachables studies provide the list of chemicals, which extract from the device – whether it is through exaggerated or simulated use conditions.
A list of chemicals is the starting point for a biological evaluation. Complete chemical characterization is paramount to a successful extractables and leachables study.
More importantly, a list of chemicals without application of how those chemicals may affect patient safety holds little weight or evidence of safety. A toxicological risk assessment of the chemistry data evaluates the patient safety. When evaluating chemicals, a toxicologist must treat an unidentified chemical or “unknown” as considered carcinogenic, or genotoxic.
Our approach to a toxicological risk assessment encompasses evaluation of each chemical, toxicological safety modeling, and calculation of tolerable intake and margin of safety. This assessment, along with fully characterized chemical data, when favorable, supports the safety assessment for systemic endpoints. This may allow the sponsor to leverage extractables and leachables studies with a toxicological risk assessment in lieu of select biocompatibility testing such as long-term systemic toxicity and genotoxicity.
Our team of toxicologists consults on test strategies and advises on a risk-based approach for preclinical device safety whether it is a submission, gap analysis or update to the design history file. They leverage the knowledge and understanding of device safety gained from the more than 700 toxicological risk assessments – with no rejections – written in the past two years.
Contact us today to learn more about our approach. Email us at firstname.lastname@example.org or call 888-794-0077.