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'Least Burdensome' Comment Deadline Delayed By US FDA

 
• By Elizabeth Orr

The deadline has been bumped back to mid-March following a request from industry trade group AdvaMed.

Stakeholders will have an extra month to comment on how US FDA should apply the "least burdensome" concept in device regulation, the agency announced Jan. 23.

In FDA device regulation, "least burdensome" signifies an approach that seeks to minimize unnecessary steps and requests on the part...

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The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.

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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.

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
• By Amanda Maxwell

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

More from Policy & Regulation

Global Medtech Guidance Tracker: May 2025

 
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More Haste Less Pace? Challenging The ‘Early As Possible’ Principle In Medtech Innovation

 
• By Stuart Grant

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• By Natasha Barrow

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.