The FDA’s Center for Devices and Radiological Health (CDRH) has announced the elevation of the Office of Strategic Partnerships and Technology Innovation (OST) to a Super Office within the Center.
This strategic move will enhance the agency’s capabilities in addressing future public health challenges while prioritizing patient voices, innovation, safety, and service excellence.
OST, established in 2019, has provided leadership and coordination on critical issues such as medical device cybersecurity, digital health, standards, and patient science. On the outside, it is in charge of initiatives associated with medical device supply chain resilience and shortage mitigation, as well as public health emergency preparedness and response. Internally, OST drives the Center’s data, technology, and IT transformation services for optimal regulatory processes.
With this elevation, OST will house five specialized offices, each with distinct focuses and responsibilities:
- Office of Supply Chain Resilience (OSCR) will enhance global medical device supply chain resilience and mitigate potential shortages.
- Digital Health Center of Excellence (DHCoE) will accelerate digital health advancement and regulatory innovation to meet evolving healthcare needs.
- Office of Technology and Data Services (OTDS) will lead CDRH’s Digital Transformation Initiative to improve user experience and data management capabilities.
- Office of Readiness and Response (ORR) will address medical device cybersecurity, readiness, response, and standards to tackle emergencies effectively.
- Office of Equity and Innovative Development (OEID) will advance health equity by fostering device innovation and ensuring access for diverse patient populations.
As part of its public health mission, OST will continue to partner collaboratively with various medical device stakeholders, including patient organizations, health care professional organizations, industry, and scientific and other organizations in the U.S. and abroad. OST’s new structure will increase organizational capabilities and advance our efforts to meet MDUFA V commitments.
