Eight Products Enter US FDA’s Opioid Challenge

After spending the past six months receiving and reviewing hundreds of product applications, US FDA has decided to select eight promising devices and diagnostics to help tackle the opioid crisis.

And then there were eight. That’s the number of products out of 250 that have been selected to participate in a new US FDA project to develop treatments to help fight the nationwide opioid crisis. They will be given special attention from the agency as their product is reviewed for market and are automatically considered for Breakthrough Device designation without having to file a separate application.

The medical devices selected to participate in the innovation challenge range from products intended to predict the risk of opioid used disorder (OUD), detect opioid overdose, dispense medication and provide...

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