Biocompatibility testing of the COSMIIC System

Case Western Reserve University, Cleveland OH

Investigators

Linked publications & trials

Abstract

Abstract Summary Biocompatibility testing of the COSMIIC System The aim of this supplement is to conduct biocompatibility testing of the COSMIIC System components, under currently accepted standards (ISO 10993-1), and to make the testing procedures and results available to the public under our open source licenses. The Specific Aims of this supplement are: Specific Aim #1 Complete a Q-Sub with the FDA to gain insights into biocompatibility requirements for a device covered in an Early Feasibility Study (EFS) Investigational Device Exemption (IDE). Specific Aim #2 Generate a comprehensive Biological Evaluation Report (BER). Specific Aim #3 Develop a toxicology risk assessment based on chemical characterization and test results. Specific Aim #4 Publish all test procedures (to the extent allowable) and all test results freely available under the COSMIIC open source licenses.