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‘Get Ahead Of The Curve’ By Preparing for EUA End, Attorneys Say

 
• By Elizabeth Orr

Two regulatory attorneys spoke to Medtech Insight about the most important steps to take before the public health emergency ends, as well as what enforcement tactics they expect to see from the FDA.

Steep grades and curves, road sign, dangerous road

With the official end of the COVID-19 public health emergency in the US just a few short weeks away, device manufacturers are gearing up for the next step: Transitioning devices that reached market under emergency use authorizations (EUAs) or other forms of enforcement discretion to a conventional US Food and Drug Administration regulatory pathway. Medtech Insight interviewed two veteran attorneys about what steps manufacturers should prioritize.

The agency issued final guidance documents explaining its three-step approach to EUA transition last month. However, the agency’s plans go...

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

 
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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.