As part of its efforts to address the opioid epidemic, the FDA launches an innovation challenge to spur the development of medical devices that could provide solutions to detect, treat, and prevent addiction, addressing diversion and treating pain.
As part of the innovation challenge, companies selected by the FDA under this new program will have the opportunity to work closely with the agency to accelerate the development and review of their products.
The goal is to provide additional incentives for product developers to invest in products that can address aspects of the addiction crisis, and advance the development of promising technologies, according to a media release from the US Food and Drug Administration.
“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,” says FDA Commissioner Scott Gottlieb, MD, in the release.
“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,” he adds.
The FDA encourages developers to submit product proposals in any stage of development, from concept to testing
The challenge also is open to developers of currently marketed devices who are interested in demonstrating that their device has an improved benefit-risk profile as compared to opioids in the management of pain.
The FDA will accept submissions from June 1, 2018, through September 30, 2018, and intends to announce the selected applicants in November 2018.
A team from the FDA’s Center for Devices and Radiological Health will evaluate the submissions based on the product’s feasibility, potential public health impact, and novelty of the concept.
Developers accepted into the challenge will receive enhanced interactions with FDA review divisions during the development and evaluation of the proposed product. In addition, Breakthrough Device designation will be granted to those devices that meet the statutory criteria for designation without submission of a separate application.
In most cases, the agency anticipates that applicants will eventually submit one or more formal applications to the FDA, such as an investigational device exemption, De Novo, premarket clearance (510(k)) or premarket approval application, the release explains.
“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. We also hope that in turn these novel products may also help pave the way for the development of future products that build on the latest technologies,” states Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in the release.
[Source(s): US Food and Drug Administration, PR Newswire]