The goal? New tech tools to fight the opioid crisis. The prize? A shot at expedited review.
Starting June 1st, those who think they have a technological advance that could help fight the opioid crisis are encouraged to submit their ideas to the FDA. The agency’s new challenge is open until September 30th, and the prize is noteworthy: A chance at expedited review and “enhanced interactions” with regulators throughout the process.
FDA Commissioner Scott Gottlieb, MD, said that medical devices and digital health interventions have potential in the fight against opioid abuse.
“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 new initiative is somewhat open-ended: Suggestive submissions could be anything from a digital tool that helps to track and prevent diversion to a device that provides non-opioid relief for acute or chronic pain (the agency’s official announcement alludes to examples of recently-approved brain and spinal cord stimulators). As long as it’s a new tech tool that could help mitigate opioid abuse, the FDA wants to listen.
Products in any stage of development—“from concept to testing”—are eligible for the challenge, and those that meet necessary criteria will be granted Breakthrough Device designation without a separate application. That said, the agency does expect that most applicants will eventually have to submit a formal application, whether a 510(k), De Novo, investigational device exemption, or premarket approval.
“The FDA stands ready to provide significant assistance and expedite premarket review of applications to help bring innovative devices that, if properly instituted, could help those at risk for addiction or treat those who might develop opioid use disorder,” the director of the agency’s Center for Devices and Radiological Health, Jeff Shuren, MD, JD, said.
The new challenge supports the Department of Health and Human Services’ 5-point strategy for fighting opioid abuse. That framework calls for better treatment and recovery services, data, research, pain management options, and targeting of overdose reversing drugs.
Selected applicants will be announced in November 2018.