FDA has launched an innovation challenge to spur the development of medical devices, including digital health and diagnostic devices, to help combat the opioid crisis and to help prevent and treat Opioid Use Disorder — a serious health condition that can be a devastating outcome of opioid drug use.
This innovation challenge is an example of the FDA’s commitment to an all-of-the-above approach to more forcefully confront the opioid epidemic, including helping those currently addicted to opioids and preventing new cases of opioid addiction. This new effort seeks to provide device developers an opportunity to work directly with FDA to accelerate the development of innovative products, such as diagnostics to identify patients at increased risk for addiction, non-opioid pain therapies for acute or chronic pain, treatments for opioid use disorder or symptoms of opioid withdrawal, as well as devices that monitor the use and prevent diversion of prescription opioids.
FDA’s Center for Devices and Radiological Health (CDRH) will accept applications for this challenge from June 1 through September 30, 2018. Medical devices that lead to the prevention and treatment of opioid use disorder are desired and their developers are encouraged to apply. 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, may also apply. Applicants accepted into the challenge will receive enhanced communications with FDA review divisions and management during the development 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.
Proposals submitted will be evaluated based on the feasibility, potential public health impact, and novelty of the concept. The number of proposals selected for the challenge will be determined by the quality of applications received and available FDA resources. FDA intends to announce the specific devices selected into the challenge in November 2018. For more information on how to apply, visit the challenge web site. On July 25, 2018, FDA will host a webinar for medical device developers to ask questions about the challenge. No registration is required to participate. Details on the webinar are posted on the CDRH Webinar website. FDA remains committed to addressing the national crisis of opioid addiction on all fronts and this challenge is part of FDA’s ongoing work to reduce the scope of the opioid crisis and supports several of overarching goals of the Department of Health and Human Services' Five-Point Strategy to Combat the Opioids Crisis.