FDA Calls For Innovative Medical Devices To Address Opioid Abuse
In response to the worsening opioid crisis, federal regulators announced the launch of an innovation challenge this week, which is aimed at spurring the development of medical devices that will help treat or diagnose opioid addiction.
The FDA Innovation Challenge: Devices to Prevent and treat Opioid Use Disorder was announced May 30, calling for developers of medical devices to submit ideas for new technology to help combat narcotic painkiller abuse and misuse.
The opioid abuse and overdose crisis has reached epic proportions. Last year, a study indicated opioid deaths now outnumber breast cancer fatalities and the problem is only worsening.
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Some research indicates doctor prescribing habits are largely to blame. Especially considering half of all patients don’t actually need opioids to help control their pain.
The new challenge focuses on helping companies develop medical devices, diagnostic tests, and digital health technologies, including mobile medical apps, that will combat the opioid crisis. The FDA indicates the sole purpose is to help prevent and treat opioid use disorder.
The agency also indicated developers of medical devices already on the market can apply if the device will improve the benefit-risk profile in the management of pain, compared to opioids. The goal is for the device to manage the patient’s pain more effectively with fewer risks than prescription opioids.
Applicants will work with the FDA to accelerate the development of the products to the review process. They will be evaluated based on feasibility, potential public health impact, and novelty of the concept.
This is only one of many steps the FDA has taken in recent months as part of the agency’s plan to combat the opioid abuse epidemic.
Opioid use disorder affects more than 2 million Americans and disproportionately impacts minority populations and older people, ages 45 to 64.
Opioids now account for two-thirds of drug overdose deaths. The Surgeon General of the United States recently urged more Americans to become familiar with naloxone, a drug used to rapidly combat the effects of opioid overdose.
The FDA will accept applications for the challenge from June 1, 2018, through September 30, 2018. The agency will announce which applicants are selected for the challenge in November 2018.
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