The US FDA split its Office of In Vitro Diagnostics and Radiological Health in two earlier this week because it “really had two flavors of technology – actually three – that sat in there,” says Jeff Shuren, director of the agency’s device center.
The US Food and Drug Administration broke up its office that handled in vitro diagnostics and radiological health earlier this week, and the head of the agency’s device center is offering insight into why that happened.
The Office of In Vitro Diagnostics and Radiological Health “really had two flavors of technology – actually three – that...
Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
