Beginning today, June 1, CDRH is accepting applications as part of an innovation challenge to encourage the development of medical devices and diagnostics that help fight the opioid crisis. Companies selected by FDA under the program will work closely with the agency to speed up the development and review of their products. A breakthrough device designation will also be granted to devices that meet statutory criteria.
“This innovation challenge is an example of the FDA’s commitment to an all-of-the-above approach to confront the opioid epidemic, including helping those currently addicted to opioids and preventing new cases of addiction,” said FDA Commissioner Scott Gottlieb, M.D. in an agency news release. “We’re hopeful that in collaborating with public health-minded innovators, we can identify and accelerate the development of new technologies, whether a device, diagnostic test, mobile medical app, or even new clinical decision support software, that can contribute in novel and effective ways to help reduce the scope of this crisis.”
The agency will accept applications from June 1 through September 30. The program applies to both products in development as well as currently marketed devices. FDA will evaluate the proposals based on feasibility, potential public health impact and novelty of the concept. The number of proposals accepted has not been determined yet and will be decided based on the quality of applications and available agency resources.
On July 25, FDA will host a webinar to answer any questions about the challenge.