Challenge to Address Opioid Crisis

On May 30, 2018, FDA launched the agency’s “Innovation Challenge” to spur the development of medical devices. These medical devices include digital health technologies and diagnostic tests that could possibly provide solutions to detect, treat, and prevent addiction by addressing diversion and treating pain.

This challenge will help companies selected by FDA to work closely with the agency to accelerate the development and review of their innovative products. The goal is to provide additional incentives for product developers to invest in products that can address the addiction crisis, but at the same time, advance the development of promising technologies.

“Medical devices, including mobile medical apps have the potential to play a unique and important role in tackling the opioid crisis” reports, FDA Commissioner Scott Gottlieb, M.D. “For example, better medical devices could possibly address local pain syndromes and in some cases, supplant the use of systemic opioids. FDA is hoping to accelerate the development of new technologies such as devices, diagnostic tests, mobile medical apps, and/or new clinical decision support software”

FDA is looking for proposals for products able to identify patients at increased risk for addiction, technologies to treat pain that eliminate the need for opioid analgesics, technologies to treat opioid use disorder or symptoms of opioid withdrawal, as well as devices or technologies that can prevent diversion of prescription opioids.

This challenge is open to products in any stage of development from concept to testing. The challenge is also open to developers of currently marketed devices that are interested in demonstrating that their device has an improved benefit-risk profile as compared to the use of opioids in the management of pain.

FDA is accepting submissions from June 1, 2018 through September 30, 2018 with the selection of applicants to be announced in November 2018. Submissions will be evaluated by a team from FDA’s Center for Devices and Radiological Health with the selection to be based on the product’s feasibility, potential public health impact, and novelty of the concept.

FDA will host a webinar on July 25, 2018 at 1 PM EST for medical device developers who have questions about the challenge. To hear the presentation, dial 888-282-0360—international callers dial 1-630-395-0147. The Conference Number is PWXW7562309 and the Passcode is 2848432.

Following the webinar, the transcript, audio recording, and slides will be available at

For questions, contact the Division of Industry and Consumer Education in the FDA Center for Devices and Radiological Health at 1-800-638-2014, 301-796-7100, or email CDRH at or



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