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Shuren: CDRH Needs More Funding For Active Surveillance, Supply Chain Monitoring

 
• By Elizabeth Orr

In a Tuesday webinar from the Alliance for a Stronger FDA, CDRH head Jeffrey Shuren said that a “politicized and toxic” environment in Washington could limit the agency’s ability to keep up with innovation and responding to new threats.

Jeff Shuren is the Director of the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration
Jeff Shuren, seen during a recent Alliance for a Stronger FDA webinar. • Source: Webinar Screengrab

The number of innovative devices receiving premarket authorization from the US Food and Drug Administration has quintupled in the last 15 years, going from 25 in 2009 to 125 in 2023. That’s an improvement device center director Jeff Shuren is rightfully proud of – just as he touts the 4,000 presubmission meetings that the agency held last year, and the dozen new or modified devices that get authorized each day.

But now, the director of the FDA’s Center for Devices and Radiological Health is raising concerns that budget constraints and...

More from Regulation

Burden Is Too Heavy For Medtechs To Go It Alone On Complex Medtech AI Projects

 
• By Amanda Maxwell

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.

FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

 
• By Elizabeth Orr

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.

HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

 
• By Natasha Barrow

Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.

EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 
• By Amanda Maxwell

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.

More from Policy & Regulation

EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 
• By Amanda Maxwell

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.

From Imitation To Action: Johns Hopkins Robot Autonomously Performs Key Step In Gallbladder Surgery

 
• By Marion Webb

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.

Remote Regulatory Assessments Become Swiss Army Knife For US FDA’s Oversight Of Facilities

 
• By Malcolm Spicer

“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.