In an effort to step back some from its role as a ringleader for the Case for Quality initiative, US FDA wants to create a "collaborative community" so various industry stakeholders can have a say in the six-year-old scheme that aims to drive a quality mindset throughout device manufacturing organizations.
US FDA is looking to form a "collaborative community" to help it step back a bit from its role as a ringleader for the Case for Quality initiative it created six years ago, the head of the agency's device center says.
Center for Devices and Radiological Health Director Jeffrey Shuren claims that by taking a more hands-off approach, FDA would help...
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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.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.
“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.
