The U.S. Food & Drug Administration has awarded a 5-year, $40 million Indefinite Delivery, Indefinite Quantity (IDIQ) contract to a combined team of two Health IT powerhouses: Edaptive and Dynanet Corporation. The combined team will continue the groundbreaking work that Dynanet began in 2003 to develop a web-based business process management solution tailored to the FDA’s complex market clearance process for medical device products. That solution, the Center Tracking System (CTS), continues to help FDA meet the short, legislatively-mandated turnaround times to approve safe medical devices for sale in the United States. CTS also supports postmarket surveillance activities related to product recalls, field inspections, and changes to products approved in the past.
Besides operating and enhancing CTS, the initial task orders for the new CDRH Submission Tracking And Reporting (CSTAR) contract will also improve a business intelligence and data warehousing solution that Dynanet first delivered in 2007. This system enables advanced analysis of medical device data, presents scorecards and dashboards to monitor organizational performance, and helps FDA meet its Congressional reporting requirements. Under the CSTAR contract, the combined Edaptive-Dynanet team will also develop a new web and mobile-enabled system that modernizes the entry and storage of medical product information.