FDA’s Center for Devices and Radiological Health (CDRH) is unveiling a new public dataset designed to help assist chemistry labs in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.
The Chemicals List for Analytical Performance (CLAP) tool is chemical dataset intended to help analytical laboratories demonstrate their ability to detect the broad range of chemicals that may be encountered in a non-targeted analysis as part of a comprehensive extractables leachables program. As a part of premarket biocompatibility evaluation for medical devices, appropriate chemical characterization is an essential step to inform the toxicological risk assessment (TRA) process and determine the benefit risk profile for a medical device.
This dataset will allow analytical chemistry labs to determine their ability to detect a broad range of potential chemicals. See the link below provided by the FDA to the first set of chemicals along with their physicochemical properties, as well as the CDRH provided results when using gas chromatography (GC) protocols. This new dataset is part of CDRH’s ongoing commitment to help reduce the burden of premarket processes, while increasing the consistency and transparency of biocompatibility assessment methods.
Through this new approach and other actions, CRDH will continue working to make the premarket review process as efficient and seamless as possible for developers and other stakeholders, while enhancing transparency around biocompatibility assessment and prioritizing safety for all devices undergoing the premarket review process.
Read the full news release from the FDA here.
Review the CLAP tool here and the Chemical Master List and Associated Physicochemical Properties here.
