Chemical Characterization in Medical Device Evaluation: Current Practices, Regulatory Requirements, and Future Directions.

Abstract

The rigorous regulatory landscape for medical devices demands meticulous chemical characterization to ensure safety and compliance. This review examines the critical role of chemical characterization within regulatory frameworks, emphasizing its importance in the approval and market entry of medical devices. Key challenges, including the complexity of sample matrices, trace-level impurity detection, and the necessity of method validation, are thoroughly explored. In addition, the review addresses the dynamic nature of regulatory requirements, analyzing how updates in international standards, such as those from the International Organization for Standardization (ISO), the American National Standards Institute (ANSI), and the Association for the Advancement of Medical Instrumentation (AAMI), or the American Society for Testing and Materials (ASTM), shape the chemical characterization process. The review discusses future directions, including advancements in analytical technologies, the potential for increased automation and standardization, and the growing significance of managing emerging contaminants. By offering a comprehensive analysis of current practices and future trends, this review highlights the essential role of chemical characterization in ensuring the development and regulation of safe and effective medical devices.