The FDA has launched an innovation challenge to push development of medical devices to prevent and treat opioid addiction.
The challenge, announced May 30, allows selected companies to work with the FDA on speeding the development and review of their products. The agency launched the initiative to provide more incentives for product developers to invest in products that can address the opioid crisis.
"Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis. We must advance new ways to find tools to help address the human and financial toll of opioid addiction," said FDA Commissioner Scott Gottlieb, MD. "For example, better medical devices that can effectively address local pain syndromes can, in some cases, supplant the use of systemic opioids. This can help reduce overall use of opioids."
The FDA encourages developers to submit proposals, which could include diagnostics to identify patients at increased risk for addiction; treatments for pain that eliminate the need for opioid analgesics; treatments for opioid use disorder or symptoms of opioid withdrawal; and technologies that prevent opioid prescription diversion.
The FDA is accepting submissions from June 1 through Sept. 30. The agency plans to announce the selected applicants in November. The FDA's Center for Devices and Radiological Health will evaluate submissions based on feasibility, potential effects on public health and novelty of the concept.