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Industry Gets Extra Month For 510(k) Revamp Comments

 
• By Elizabeth Orr

The US FDA has extended the comment period on proposed changes to the 510(k) process until May 22, giving stakeholders an extra 30 days. The controversial proposal would publicize devices that used older predicates.

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Stakeholders have an extra 30 days to respond to a US FDA proposal to publicize devices that used older predicates, the agency announced on April 11.

The FDA wants to put a list online of devices using predicates more than a decade old as a way to discourage the use of older predicates, which may rely...

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Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
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Pathogen Sharing System Part Of Global Pandemic Agreement

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

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Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

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