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CLSA Wire

FDA Announces Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder

June 5, 2018
By Jenny Nieto Carey

On May 30, 2018, the US Food and Drug Administration (FDA) launched an “Innovation Challenge” intended to spur the development of medical devices (including diagnostic tests and digital health technologies) to help combat the opioid crisis and achieve the goal of preventing and treating opioid use disorder. Specifically, the Challenge invites medical device innovators to submit proposals for 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.” A press release from FDA announcing the Innovation Challenge is available here.

The FDA’s Center for Devices and Radiological Health (CDRH) will accept applications for this challenge through Sept. 30, 2018. Full information on the Innovation Challenge, including detailed instructions for applicants, is available here.

FDA particularly “desires medical devices that lead to the prevention and treatment of opioid use disorder” and the developers of such products 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.  In its announcement, FDA notes that submitted proposals “will be evaluated based on the feasibility, potential public health impact, and novelty of the concept.” The number of proposals selected into the Challenge will be determined by the quality of applications received and available FDA resources. The FDA intends to announce applications selected for the Challenge in November 2018.

CDRH is hosting a webinar Wednesday, July 25, 2018 at 1:00 p.m. EST (10:00 a.m. PST) for device developers to learn more about the Innovation Challenge (information about the webinar is available here).

While CLSA does not provide technical regulatory support, should you have any questions about the opportunity, please contact Jenny Carey, CLSA’s vice president of federal government relations and alliance development (jcarey@califesciences.org or 202-743-7559).