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'Least Burdensome' Supersized? Draft Guidance Outlines An Expanded View Of The US FDA Concept

 
• By David Filmore

The US agency issued a draft guidance that brings the 20-year old concept of "least burdensome" in medical device regulation to all corners of the device center's activities.

While US FDA's new draft guidance on the "concepts and principles" of the least burdensome provisions was prompted in part by last year's enactment of the 21st Century Cures Act, it is intended to go further than that, says device-center director Jeffrey Shuren.

"The approach that we are taking on least burdensome goes beyond what Congress has put into the law," Shuren told Medtech Insight

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More from Policy & Regulation

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

UK Medtech Regulators Must Ensure Certainty So Businesses Can Plan Their Futures

 
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First At-Home Cervical Cancer Screening Tool Gets FDA Clearance

 
• By Elizabeth Orr

The US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after.