On February 15, numerous probationary staff at FDA began receiving emails notifying them they had been fired. “Unfortunately, the Agency finds that you are not fit for continued employment because your ability, knowledge and skills do not fit the Agency’s current needs, and your performance has not been adequate to justify further employment at the Agency,” said the letters.
The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has developed a discussion paper, Health Equity For Medical Devices, and seeks input from the public on advancing health equity on the context of medical devices.
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).
Learn how your peers in MedTech assess and mitigate risks and improve logistics to build more sustainable, resilient supply chains.
On May 16-17, device developers, regulatory affairs and regulatory intelligence professionals will come together in Washington, DC, for two days of education, discussion and networking to share strategies and best practices on navigating current and on the horizon regulatory requirements.
Unhappy with current textbooks and resources for regulatory professionals, Elijah Wreh, Professor of Regulatory Science and Senior Manager Regulatory Affairs at Boston Scientific, authored his own book for industry and future regulators.
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.
