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European Commission Launches Data Collection Initiative To Avoid Medtech Product Shortfalls

 
• By Amanda Maxwell

There is a much-acknowledged urgency to ensure medtech products are certified as fast as possible, with fears persisting that delays will result in notified body bottlenecks and product shortages.

Data Collection - Three Arrows Hit in Red Target

An EU initiative has now begun to collect data on all medical devices and IVDs circulating on the EU market. Its deadline is 15 January 2024.

The Surveys for MD and IVD manufacturers and authorised representatives, published in the context of the European Commission’s study...

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Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
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The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

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FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
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Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

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SAGA Diagnostics Launches Early Breast Cancer MRD Detection Test In US

 
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