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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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MHRA’s Tallon Hails PMS Regulation As Start Of UK Device Framework Transformation

 
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16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.

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UK Healthtech Center Of Excellence Given Key MHRA Digital Regulation Role

 
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Where Do Questions Surrounding The EU’s AI Act Leave The Medtech Industry?

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

More from Policy & Regulation

MHRA’s Tallon Hails PMS Regulation As Start Of UK Device Framework Transformation

 
• By Ashley Yeo

16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.

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With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
• By Brian Bossetta

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?