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FDA Seeks To Spur Innovation In Devices Designed To Treat Opioid Abuse

 
• By Brian Bossetta

Draft guidance from the US Food and Drug Administration provides recommendations for the development of medical devices to treat opioid use disorder and considerations for sponsors of clinical studies to evaluate them.

OPIOID CRISIS
• Source: Shutterstock

The complexity of opioid use disorder (OUD) makes it difficult to treat, including for device designers looking to help tackle what the US Food and Drug Administration calls a “national crisis.”

To facilitate innovation in the development of devices to treat OUD, the FDA recently published draft guidance to help sponsors

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Does Makary’s Reorg Choice Mark FDA Turning Point?

 
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