FOR IMMEDIATE RELEASE
January 24, 2024
The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) and Suzanne Schwartz, M.D., M.B.A., director of the Office of Strategic Partnerships and Technology Innovation (OST), CDRH
CDRH is pleased to announce that, effective immediately, the Office of Strategic Partnerships and Technology Innovation (OST) has been elevated to a Super Office within the Center. The Super Office designation allows the Center, specifically OST, to be well-positioned and capable of adapting to and addressing future public health needs and challenges while continuing to advance the voice of patients, innovation and safety, regulatory science, and service excellence with our customers.
OST was stood up in 2019 as part of the Center’s vision to create an agile infrastructure capable of adapting to future organizational, regulatory, and scientific needs. Externally, OST provides leadership and strategic direction on medical device cybersecurity, digital health, standards, and patient science while providing oversight and coordination for CDRH in matters relating to public health emergency preparedness and response activities such as medical device supply chain resilience and shortage mitigation. Internally, in addition to providing expertise and program support in the above areas, OST directs the Center’s data, technology, and IT transformation services to ensure effective design, development, and utilization of information systems, electronic data, and analytic capabilities to optimize regulatory business processes.
By elevating OST to a Super Office, several organizational shifts will occur, including the establishment of the following five offices within OST: Office of Supply Chain Resilience (OSCR), Digital Health Center of Excellence (DHCoE), Office of Technology and Data Services (OTDS), Office of Readiness and Response (ORR), and Office of Equity and Innovative Development (OEID).
Key Office Highlights
- OSCR will lead our Medical Device Resilient Supply Chain and Shortages Program to enhance, foster, and sustain resiliency in global medical device supply chains, as well as rapidly identify potential device shortages and mitigate and prevent device shortages.
- The elevation of the DHCoE to an office will allow the program to best meet today’s emerging challenges, particularly as digital health technologies play an increasing and significant role in bringing health care to the local community and into the home. Launched in the Fall of 2020, the DHCoE aims to connect and build partnerships to accelerate digital health advancement, share knowledge to increase awareness and understanding, drive synergy, advance best practices, and innovate regulatory approaches to provide efficient and least burdensome oversight while meeting FDA standards for safe and effective products.
- OTDS will continue to shepherd CDRH through and beyond our Digital Transformation Initiative, which aims to significantly improve the user experience for both internal and external CDRH customers and enhance CDRH’s ability to accept, store, analyze, and distribute data, and digitalize CDRH’s programs and operations. These efforts will support ongoing IT and data management needs to continually evolve and sustain the critical IT and data infrastructure that enables CDRH to meet our public health mission.
- ORR will address the areas of Medical Device Cybersecurity, Readiness and Response, and Standards. The office will further our readiness posture to tackle emergencies and public health threats, as well as drive the development, recognition, and appropriate use of voluntary consensus standards for medical devices. The new division dedicated to medical device cybersecurity will continue to support CDRH’s efforts to advance the cybersecurity posture of the medical device ecosystem and advance our national preparedness, response, and coordination for cybersecurity incidents involving medical devices by enhancing collaborations, optimizing operational responsiveness, and leveraging CDRH regulatory science capabilities through an integrated approach.
- The new OEID will be focused on advancing health equity by fostering device innovation that expands access to diverse patient populations, including underserved populations, and ensuring all patients have access to medical devices informed by solid patient science and engagement.
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, as well as our 2022-2025 Strategic Priorities.
CDRH remains committed to serving the American public and ensuring our organization is well-positioned to fully achieve our mission and vision and meet emerging public health needs.
- Office of Strategic Partnerships and Technology Innovation
- OST Super Office Reorganization Frequently Asked Questions (FAQs)
- CDRH Management Directory