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