Innovative Digital Health Devices Regulatory Review and Evaluation Capability

The Food and Drug Administration is seeking to establish a contract-supported capability to design, pilot, and operationalize an end-to-end review model for the Digital Health Center of Excellence. This initiative focuses on the regulatory review and evaluation of innovative digital health medical device submissions to streamline and enhance the oversight process. While the contractor will provide the framework and operational support for this model, all final regulatory review judgments and official decisions will remain the sole responsibility of federal personnel within the Center for Devices and Radiological Health. This forecast outlines a strategic effort to modernize how digital health technologies are evaluated for safety and efficacy.