1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

FDA’s Draft QMSR: 3 Experts Read More Stakeholder Comments So You Don’t Have To

Part Two Of Two

 
• By Shawn M. Schmitt

The second of two parts: Industry experts Vincent Cafiso, Kim Trautman and Dennis Gucciardo spoke with Medtech Insight about noteworthy comments on the US FDA’s proposed Quality Management System Regulation.

A stakeholder.
Stakeholders had their say on the FDA's proposed quality systems rule • Source: Shutterstock

As of 1 June the US Food and Drug Administration has released online 69 stakeholder comments on its draft Quality Management System Regulation. When finalized, the QMSR will replace the agency’s aging Quality System Regulation (QSR).

The QMSR is a result of the FDA’s years-long initiative to harmonize the QSR with international quality systems standard ISO...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

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.