Center for Devices and Radiological Health Reorganization – Implementation to Begin

The Center for Devices and Radiological Health (CDRH) is beginning implementation of a reorganization that will create an agile infrastructure that can adapt to future organizational, regulatory and scientific needs.

Since June 2018, we have been piloting a more integrated approach to device safety throughout the Total Product Life Cycle (TPLC). Although CDRH has applied a TPLC approach to the regulation of devices for many years, the reorganization will enhance communication among CDRH staff and enable more efficient activities across the life cycle from premarket review to postmarket surveillance.

Implementation of our reorganization will begin on March 18, 2019 with a goal of completing full implementation by September 30, 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.

Impact of CDRH Reorganization

After full implementation, the reorganization will integrate CDRH’s premarket and postmarket program functions along product lines, allowing our 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.

Contacting CDRH

Individuals should continue to communicate with their current contacts in CDRH or use theCDRH Management Directory to find the best Center contact for a specific issue. As implementation is finalized throughout CDRH, we will update our Reorganization of CDRH page on FDA.gov and the CDRH Management Directory to reflect CDRH’s new structure.

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Questions?

If you have general questions about the reorganization, medical devices or radiological products, contact the Division of Industry and Consumer Education.