FDA Pitches 'Innovation Challenge' to Boost Development of Devices to Treat Opioid Use Disorder
In an attempt to incentivize the development of new medical devices to treat or prevent opioid use disorder, the US Food and Drug Administration (FDA) on Wednesday announced an "innovation challenge" for device makers that will run from 1 June to 30 September 2018.
"Applicants selected for the challenge will work directly with the FDA to accelerate the development of and eventual review of marketing applications for innovative products, similar to what occurs under the breakthrough devices program," FDA writes, adding that breakthrough device designation will be granted to products accepted to the challenge that meet the statutory requirements for the designation without needing to apply separately for it.
Some examples of devices that could qualify for the challenge include devices that reduce or replace the need for opioids in pain management and diagnostics that identify patients who are at an increased risk for developing an addiction.
FDA says it will evaluate the submissions it receives and select applicants based on their proposed product's feasibility, potential public health impact and novelty.
"Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis. We must advance new ways to find tools to help address the human and financial toll of opioid addiction," said FDA Commissioner Scott Gottlieb.
Gottlieb noted the challenge fits in with FDA's "all-of-the-above approach" to addressing the opioid epidemic.
To apply for the challenge, device makers must submit an application to FDA by 30 September detailing the intended use of the device, the company's development plan, the team behind its development and the device's potential benefit and impact to public compared to existing products.
After being accepted, FDA says it will expedite the review of future formal submissions, including investigational device exemption (IDE), de novo, 510(k) and premarket approval (PMA) submissions.
In November, FDA cleared Innovative Health Solutions' NSS-2 device, a small electrical nerve stimulator, as the first medical device to reduce the symptoms of opioid withdrawal. Earlier this month the agency also approved US WorldMeds' Lucemyra (lofexidine hydrochloride) as the first non-opioid indicated to manage opioid withdrawal symptoms.