US FDA Nov. 20 announced plans for a broad series of updates to its Medical Device Safety Action Plan for the next several months, with the goal that FDA "is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.
USFDA is implementing a vigilant post-market surveillance system by initiating new device monitoring steps starting now and through early 2019, to quickly identify new or increased safety concerns with medtech products, Commissioner Scott Gottlieb said Nov. 20.
“After carefully considering public feedback, we’ll be announcing in a series of updates several important new actions that will help...
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.
