Healthcare DIVE March 24, 2023
The agency is providing a 180-day transition period for devices that were exempted during the pandemic, and said companies that currently have an EUA should start preparing.
With the COVID-19 public health emergency set to expire on May 11, medical technology companies that brought devices to market under special pandemic rules will need to prepare transition plans soon, the Food and Drug Administration said in final guidance issued on March 24.
The agency clarified what steps medtech firms will need to take if their product had an emergency use authorization (EUA), or was marketed under a pandemic exemption.
For devices with an EUA:
Device EUAs won’t expire immediately when the public health emergency ends, the FDA said. Rather, the Health...
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