The U.S. Food and Drug Administration announced this week that it is launching an innovation challenge to spur the development of medical devices, including digital health technologies and diagnostic tests, that could provide novel solutions to detecting, treating and preventing addiction, addressing diversion and treating pain.
The innovation challenge is part of the agency’s ongoing work to address the epidemic of opioid misuse and abuse, and the challenge will provide those companies that are selected by the FDA under this new program with the opportunity to work closely with the agency to accelerate the development and review of their technology 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,” the FDA stated.
“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,” FDA Commissioner Scott Gottlieb, M.D., said in a statement. “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. This innovation challenge is an example of the FDA’s commitment to an all-of-the-above approach to confront the opioid epidemic, including helping those currently addicted to opioids and preventing new cases of addiction. 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.”
The FDA will accept submissions from June 1, 2018, through Sept. 30, 2018, and intends to announce the selected applicants in November 2018. Submissions will be evaluated by a team from the FDA’s Center for Devices and Radiological Health based on the product’s feasibility, potential public health impact, and novelty of the concept.
According to the FDA, proposals could include products such as diagnostics to identify patients at increased risk for addiction, treatments for pain that eliminate the need for opioid analgesics (such as opioid-sparing or replacement therapies for acute or chronic pain), treatments for opioid use disorder or symptoms of opioid withdrawal, as well as devices or technologies that can prevent diversion of prescription opioids.
What’s more, the challenge is open to products 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.
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.
“This new effort builds on the success of previous work to take a collaborative approach to promoting medical device innovation and safety, such as the 2012 challenge that led to multiple new approaches to treat life-threatening, end-stage renal disease,” Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said in a statement.
