Meeting March 19-21 in France, the International Medical Device Regulators Forum announced a major new project on standalone device software and the upcoming release of several guidance documents for public comment.
The newly created International Medical Device Regulators Forum (IMDRF) took steps to strengthen its role in setting global device policies last month, adding new projects to its already ambitious agenda and expanding its core membership to include regulators from China.
Reporting on the group's March 19-21 meeting in France, Kimberly Trautman, associate director for international affairs in FDA's device center...
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.
