The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) is beginning to implement a reorganization that will, according the the Agnecy, “create an agile infrastructure that can adapt to future organizational, regulatory and scientific needs”.
Since June 2018, CDRH has been piloting a more integrated approach to device safety throughout the Total Product Life Cycle (TPLC) process. Although CDRH has applied a TPLC approach to the regulation of devices for many years, the reorganization will enhance communication among CDRH staff and allow more efficient activities across the life cycle, from premarket review to postmarket surveillance.
Implementation of the reorganization will begin on 18 March 2019 with the goal of completing full implementation by 30 September 2019. Each office within the current CDRH structure is undergoing some change to better support and advance CDRH’s public health mission and vision. Implementation will take place in a phased approach, and timelines for implementation will vary by office.
The Agency explains further that: “After full implementation, the reorganization will integrate CDRH’s premarket and postmarket program functions along product lines, allowing CDRH experts to leverage their knowledge to optimize decision-making across the product life cycle. This type of structure consolidates and integrates many of the current aspects of product review, quality, surveillance and enforcement into a new, team-based approach. Full implementation of the new structure will increase information-sharing across the Center, enhance collective decision-making, and improve work-life balance and increase professional opportunities for employees.”