COVID-19 Quick-Response FDA Compliance for Medical Device Manufacturers

On 03/31/2020

Here's what manufacturers redirecting their efforts towards COVID-19 countermeasures need to know. The Food and Drug Administration (FDA) has taken measures to provide medical device manufacturers developing countermeasures against COVID-19 with a fast-track option for obtaining FDA authorization and liability immunity. (This article is intended only for educational purposes, not to provide legal or business […]

Seeking FDA De Novo Classification for Innovative Medical Devices

On 04/23/2019

Medical device manufacturers that develop novel new products may face a challenge when seeking FDA regulatory compliance If a new device represents a significant innovation, then it may not be seen as substantially equivalent to any pre-existing products. Creating a groundbreaking new technology is great, except when it comes to assessing its potential risk […]

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COVID-19 Quick-Response FDA Compliance for Medical Device Manufacturers

Seeking FDA De Novo Classification for Innovative Medical Devices