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FDA Plans To Use Third Parties To Review LDTs

 
• By Elizabeth Orr

The FDA expects that outside reviewers will be able to handle about half of all lab-developed test submissions, a spokesman told Medtech Insight. Meanwhile, a recent CDRH memo discussing COVID-19 test validation offers further background on why the agency is concerned about LDT accuracy and reliability.

• Source: Alamy

The US Food and Drug Administration is responding to the storm of commentary around its proposed rule on lab-developed tests with additional explanations, a memo from device-center official Elizabeth Hillebrenner, and plans for a webinar at the end of this month.

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Keeping Germany’s Medtech Industry Apprised, Advised and Incentivized in Turbulent Times

 
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More from Policy & Regulation

Notified Bodies Warn Of Hurdles In The Way Of Their AI Designations

 
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Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?

Guidance Feedback Highlights Outstanding Questions In AI Development

 
• By Elizabeth Orr

Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.

Keeping Germany’s Medtech Industry Apprised, Advised and Incentivized in Turbulent Times

 
• By Ashley Yeo

A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.