FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder!
This is an interesting proposal for medical device industry from the President’s administration to help push an end to the opioid crisis.
The FDA issued an innovation challenge to create devices to prevent opioid abuse and treat those who are already addicted. Applications will be accepted from June 1st through September 30th of 2018 for the challenge. This challenge is primarily intended for diagnostic or therapeutic medical devices that address the opioid epidemic. Submissions should describe, the novelty of the medical device or concept, the development plan for the medical device, the development team, and the anticipated benefits of the device when used by patients as well as the impact on public health compared to the alternatives. Medical devices at any stage in development are eligible. Any developer that submits their device will receive enhanced interactions with the FDA review division as a means to expedite the review process.
To submit an application for this challenge it must be sent electronically to CDRH-Innovation-Opioid@fda.hhs.gov on or before September 30th, 2018. Applications selected for the challenge will be announced in November of 2018, as many applications as resources permit will be selected. Applications should be no longer than 7 pages using Times New Roman, 12-point font, written in English and submitted in a PDF format. Applications will contain a cover page, executive summary and the proposal which will contain the device description and indication for use, the significance of the successful development of the device, the device development plan, the quality of the development team, a manufacturing plan, and value of FDA input. For a more in-depth list of requirements please visit https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/ucm609082.htm
We at MDI are happy to assist any developers who may be interested in entering this challenge.? For any questions or comments or your regulatory requirement please email to firstname.lastname@example.org or use our contact form.