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Industry Experts Give FDA’s Pre-Cert Program Thumbs-Up

 
• By Brian Bossetta

A panel of industry experts gave the US FDA’s Digital Software Precertification Program the thumbs-up during a MedCon session.

FDA Shadow
• Source: Alamy

When the US Food and Drug Administration introduced its Digital Health Software Precertification (Pre-Cert) in 2017, the idea was to create a streamlined process for more efficient regulatory oversight of software-based medical devices.

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Trump’s Preliminary 2026 HHS Budget Plan Protects US FDA User Fee Collection

 
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The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

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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?

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.

More from Policy & Regulation

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

 
• By Amanda Maxwell

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Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples.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.