FDA Launches Initiative to Accelerate Opioid-Oriented Device Development

In a move to combat the opioid crisis, the FDA launched an “innovation challenge” to stimulate the development of medical devices that could provide novel pain treatments and help prevent, detect and treat opioid addiction.

The agency is encouraging developers to submit proposals from June 1 to September 30, including for products such as treatments for pain that do not require opioid analgesics, treatments for opioid withdrawal or opioid use disorder, diagnostics for detecting patients at increased risk for addiction, and technologies that can prevent diversion of prescription opioids.

The challenge is open to products in any stage of development and extends to developers of currently marketed devices who want to demonstrate that their device has an improved benefit-risk profile for pain management compared to opioids.

Applicants chosen by the FDA — to be announced in November — will work with the agency through “enhanced interactions” to accelerate the development and review of their innovative devices, giving developers more incentives to invest in products that can help address the opioid crisis and advance promising technologies.

“Medical devices, including health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis,” said FDA Commissioner Scott Gottlieb. “We must advance new ways to find tools to help address the human and financial toll of opioid addiction.” — James Miessler