The U.S. FDA today announced that it has launched an innovation challenge to encourage the development of medical devices to help reduce the country’s opioid abuse crisis.
The hope is that the challenge will result in new medtech including digital health technologies and diagnostic tests to help detect, treat and prevent addiction, according to FDA.
Companies selected by the FDA under the new program will work closely with the agency, with accelerated development and review of their products. In addition, FDA will grant breakthrough device designation to those devices that meet the statutory criteria for designation, without the companies having to submit a separate application.
“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,” Dr. Scott Gottlieb, FDA’s commissioner, said in a news release.
The roots of the prescription opioid overdose crisis in America go back to the late 1990s, when pharmaceutical companies touted prescription painkillers that weren’t supposed to be addictive but actually were. Medical professionals more frequently prescribed opioid painkillers, and opioid-related deaths steadily increased. Tens of thousands of people have been dying annually, according to the Centers for Disease Control and Prevention.
Gottlieb noted that medical devices that can effectively address local pain syndromes could, in some cases, even supplant use opioids to treat pain — reducing the need for the potentially addictive drugs.
“We’re hopeful that in collaborating with public health-minded innovators, we can identify and accelerate the development of new technologies — whether a device, diagnostic test, mobile medical app or even new clinical decision support software — that can contribute in novel and effective ways to help reduce the scope of this crisis,” Gottlieb said.
The challenge is open to products in any stage of development, from concept to testing, as well as developers of currently marketed devices who want to demonstrate an improved benefit-risk profile for their devices.
FDA is accepting submissions from June 1 through Sept. 30, and plans to announce selected applicants in November after evaluation by a team at FDA’s Center for Devices and Radiological Health.
FDA in recent years has already cleared, granted or approved more than 200 devices to help treat or manage pain; 10 of them involved new or novel technologies including brain and spinal cord stimulators to relieve pain. FDA also recently granted a new indication to an electric stimulation device that could help reduce the symptoms of opioid withdrawal.