Tag Archives: FDA CDRH

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FDA Elevates Office of Strategic Partnerships and Technology Innovation to CDRH Super Office

By MedTech Intelligence Staff
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As part of its reorganization of the CDRH, the FDA has elevated the Office of Strategic Partnerships and Technology Innovation (OST) to a Super Office that will include the 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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Jack Cronenwett, MD
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How Real-World Evidence Helps Medical Device Manufacturers Drive Value

By Jack Cronenwett, MD
Jack Cronenwett, MD

More and more, the quality of real-world evidence (RWE)—gathered from remote patient monitoring data, product and disease registry data, and patient feedback—determines whether a medical device is approved and, in some instances, for how long. Yet some medical device manufacturers are missing an important opportunity to collaborate with clinical registries in capturing this data and driving value.

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