FDA issued a draft guidance for industry and FDA staff on Chemical Analysis for Biocompatibility Assessment of Medical Devices. Any medical device in which all or part of the device is in contact with the human body requires an assessment of the biocompatibility of that device or device component as part of the premarket submission.
The type of data and/or testing required for the assessment of biocompatibility varies, based on the nature of the device, its characteristics, and the intended use. The biocompatibility of a medical device is often evaluated using in vitro and in vivo biological testing as delineated in the International Standard ISO 10993. Chemical characterization is an approach that device manufacturers can consider when developing a strategy for the assessment of overall biocompatibility. Chemical characterization can be an alternative to biological testing or reduce animal testing for evaluating some biocompatibility endpoints when employed with toxicological risk assessment. This guidance delineates various approaches to the chemical characterization of the device, including methodologies for extraction, chemical analysis, identification, use of reference standards, data reporting, and a process diagram for chemical identification. Facet is currently working with several Sponsors to establish appropriate testing for biocompatibility.