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COVID-19: FDA Tells Test Makers How To Minimize Effects Of Variants

 
• By Brian Bossetta

The US Food and Drug Administration has taken additional steps to ensure mutations of the COVID-19 virus do not negatively impact the efficacy of tests.

COVID variants.
• Source: Alamy

Manufacturers of COVID-19 tests that reached the market via the emergency use authorization (EUA) process will need to collect additional information to help mitigate risks posed by viral mutations, the US Food and Drug Administration said in a 23 September letter.

The letter requires developers of molecular, antigen and serology tests to monitor emerging viral mutations and their potential impacts on...

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

 
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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

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

 
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