FDA has just released a draft guidance for Chemical Analysis for Biocompatibility Assessment of Medical Devices.
As described in FDA’s biocompatibility guidance “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process,’” biocompatibility is evaluated through a risk management process. Potential biocompatibility risks are identified through risk assessment of a device and then mitigated using relevant information.
Chemical characterization is used to characterize the chemicals that may be released from the medical device to the body. Additionally, chemical characterization can be considered as an alternative to biological testing for evaluating certain biocompatibility endpoints when used in conjunction with toxicological risk assessment (TRA).
Given that current biocompatibility guidelines do not specify detailed methodology on how to perform extractables studies and chemical analysis of device extracts, inconsistent analytical chemistry reports and deficiencies are frequently identified. This new draft guideline provides manufactures different approaches for conducting chemical characterization as part of the biocompatibility assessment for a device. More specifically, it promotes consistency and reliability of analytical chemistry studies and to facilitate more efficient review of these studies in premarket submissions, while aligning with ISO 10993- 18 and other relevant consensus standards where applicable.