As part of its reorganization of the Center for Devices and Radiological Health (CDRH), the FDA has elevated the Office of Strategic Partnerships and Technology Innovation (OST) to a Super Office within CDRH.

Launched in 2019, the OST was designed create an agile infrastructure capable of adapting to future organizational, regulatory and scientific needs. It provides leadership for all scientific collaborative and emerging technology related activities at CDRH. In its announcement of the change, FDA stated that 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.”

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 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).

Office Roles and Responsibilities:

• OSCR will lead the FDA’s Medical Device Resilient Supply Chain and Shortages Program.
• The DHCoE, launched in 2020, will work 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 for digital health products while meeting FDA standards for safe and effective products.
• OTDS will continue to shepherd CDRH through its 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.
• ORR will address the areas of Medical Device Cybersecurity, Readiness and Response, and Standards. The office will further FDA’s 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.

OST will continue to partner collaboratively with various medical device stakeholders, including patient organizations, healthcare professional organizations, industry and scientific and other organizations in the U.S. and abroad.