Keunbong Do

Keunbong Do

Morrison & Foerster LLP

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FDA Issues Final Transition Guidances For COVID-19 Devices

This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or...more

3/31/2023  /  Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Medical Devices , Public Health Emergency

FDA Clarifies The Human Factors Or Usability Information To Include In A Device Marketing Submission

If you are a device manufacturer, what human factors and usability information should you include in your marketing submission? What if your device has the same user interface as an existing device?...more

1/12/2023  /  Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Marketing , Medical Devices
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