30 May 2018 - Agency will work closely with selected applicants to accelerate product development.
As part of the agency’s ongoing commitment to address the epidemic of opioid misuse and abuse, the U.S. FDA today launched 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.
Despite recent advances in some of these areas, there are still many opportunities to advance new technologies and bring new products to market to meet this urgent public health need. This 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 innovative 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.