FDA Office of Strategic Partnerships and Technology Innovation Elevated to Super Office

The CDRH Office of Strategic Partnerships and Technology Innovation (OST) has been elevated to a super office, effective immediately, a designation that the FDA says will allow OST to adapt to and address future public health needs and challenges.

OST was established in 2019 to give CDRH an agile infrastructure capable of adapting to future organizational, regulatory, and scientific needs. The office provides stakeholders with strategic direction on medical device cybersecurity, digital health, standards, and patient science while giving oversight and coordination for CDRH in public health emergency preparedness and response activities such as medical device supply chain resilience and shortage mitigation.

The change means the establishment of five offices: 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).

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