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FDA Issues New COVID-19 EUA Requirements After HHS Restores Agency’s LDT Oversight Role

 
• By Elizabeth Orr

A controversial Trump-era policy that blocked the US FDA from regulating laboratory-developed tests was binned by the Health and Human Services secretary on 15 November. As a result, the FDA will once again require emergency use authorizations or other clearances for new COVID-19 tests.

FDA entrance sign 2016

The US Department of Health and Human Services (HHS) has withdrawn a controversial 2020 dictate that blocked the Food and Drug Administration from regulating laboratory-developed tests (LDTs), allowing the agency to impose new requirements on submissions for COVID-19 diagnostics.

The FDA’s revised policy for COVID-19 tests, issued on 15 November, says new diagnostics should get an OK from...

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From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

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Guidance Details EU Approach On Medtech, AI Regulation Interplay

 
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UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 
• By Natasha Barrow

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Newborn Screening Tests Among FDA Classifications

 
• By Elizabeth Orr

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Will Kennedy And Makary Come To Terms On User Fees During Next Round Of MDUFA Negotiations?

 
• By Brian Bossetta

It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.