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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 into effect when pandemic-era policies are revoked – meaning that...

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