Device Chemical Analysis for Biocompatibility

FDA is announcing an 11/6 public workshop entitled “Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices.” The workshop is intended for the agency to discuss the expansion of the Accreditation Scheme for Conformity Assessment (ASCA) program to include chemical analysis to support biocompatibility of medical devices, according to an agency notice. It will focus on stakeholders’ experiences associated with analytical chemistry testing used for medical devices’ toxicological risk assessments. “The public workshop is intended to facilitate the sharing of information about analytical chemistry testing and the discussion of pathways for expanding the ASCA program to include standardized approaches to chemical analysis (e.g., ISO10993-18 Biological Evaluation of Medical Devices. Part 18: Chemical characterization of medical device materials within a risk management processExternal Link Disclaimer),” it says.