FDA Seeks Innovative Devices to Treat Opioid Use Disorder

The FDA is moving ahead with its plan to speed reviews of medical devices and diagnostics that prevent or treat opioid use disorder. The agency invited applications by Sept. 30 and said it will announce the “innovation challenge” winners in November.

Applicants selected for the challenge will work directly with the agency to accelerate development and premarket review. The agency said it will evaluate proposals based on the feasibility, potential public health impact and novelty.

The challenge is part of the FDA's ongoing work to reduce the scope of the opioid crisis and supports several of those overarching goals, said Michelle Tarver, CDRH’s director of patient science and engagement, during a recent FDA webinar outlining the challenge and its application process.