Development of guidelines for nanobiosensor evaluation as medical devices

To use nanobiosensors as diagnostic devices, they should be evaluated and approved as medical devices before marketing. This study was performed to establish appropriate evaluation guidelines that provide how to verify the safety and effectiveness of a novel nanobiosensor as a medical device. We prepared an enzymeless glucose sensor with nanoporous platinum electrode to evaluate performance and stability by comparing it with a commercial enzyme-based glucose sensor. Through these evaluation studies, we developed guidelines, and the guidelines consist of five parts: evaluation of analytical performance, clinical performance, safety, stability, and design and quality control systems. Analytical and clinical performance of nanobiosensors should be evaluated by accuracy, sensitivity, reproducibility, cut-off value, and other specific performance characteristics. Also, electric, mechanical, and biological safety should be evaluated. With the performance and safety, validation of storing conditions and shelf life should be established with evaluation and characterization of nano-structured parts for stability evaluation. Then, design and quality control systems should be evaluated in the aspect of quality requirements, material, manufacturing process, and final product. These guidelines will be helpful for facilitating the commercialization of the safe, effective, and novel diagnostic nanobiosensors into market place.