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QSR Q&A: 5 Top Medtech Experts Answer 6 Burning Questions About FDA’s Coming Quality Reg Redo

 
• By Shawn M. Schmitt

For this “man on the street” feature, Medtech Insight rounded up industry experts Kim Trautman, Vincent Cafiso, Steve Niedelman, Kwame Ulmer and Josh Levin to answer six questions about the upcoming draft harmonized Quality System Regulation from the US FDA.

colorful paper with question mark as background.

Medical device manufacturers and other industry stakeholders are waiting for the draft harmonized Quality System Regulation from the US Food and Drug Administration with breath that is bated. The agency has been working on the QSR redo – which better aligns the decades-old rule with international quality systems standard ISO 13485:2016 – for more than three years now.

The draft QSR, which will become the bedrock rule for manufacturing safe and effective devices in the US when finalized, is expected to come this year. (Also see "After...

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Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

More from Policy & Regulation

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Pathogen Sharing System Part Of Global Pandemic Agreement

 
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Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.