The agency has launched a pilot that will allow makers of cardiac diagnostic and peripheral interventional devices to submit 510(k)s in electronic-only format. FDA says it expects the program to improve both speed and quality of submissions.
FDA hopes that a new pilot program for accepting electronic-only 510(k)s will be for device makers what TurboTax is for taxpayers: a guided computer interface that accelerates and improves the quality of submissions.
The Centers for Devices and Radiological Health (CDRH) eSubmissions Pilot Program launched April 30 as the agency’s first foray into...
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.
