(43d) Experience with Regulatory Issues for Biomedical Devices and Vision for the Use of Advanced Control In Pharmaceutical Operations

The landscape for clinical testing of biomedical devices has evolved rapidly over the last 5-10 years. In particular, the use of advanced control algorithms, such as model predictive control, are now being reviewed by the FDA as components of closed-loop devices. In our work with the Artificial Pancreas (AP), we have developed master files and other supporting materials to support IDE (Investigational Device Exemption) studies. In this talk, I will share some of the challenges in developing algorithms for regulatory review, including the role of simulation studies, communication architectures, algorithmic design, and IDE studies. I will extrapolate from these experiences to project the opportunities for advanced control in pharmaceutical operations.