The FDA has selected eight medtech companies to develop devices to help reduce the country’s opioid abuse crisis.
More than 250 companies submitted entries to the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder, announced in May. Those selected include Masimo Corp. and deep-brain-stimulation company Brainsway Ltd. The companies will be expected to produce devices intended to predict the risk of opioid used disorder (OUD), detect opioid overdose, dispense medication and provide pain treatment alternatives to opioids.
The selected firms will work closely with the agency on accelerated development and review of their products. The FDA said it will grant breakthrough device designation to those devices that meet the statutory criteria for the designation, without the companies having to submit a separate application.
Participating companies and the FDA will enter a 90-day collaboration to reach agreement on the device’s profile, including patient and user needs, risks and benefits, and to discuss the potential regulatory pathways going forward. Applicants will eventually submit one or more formal applications to the FDA, which will expedite their review times. The regulatory standard of demonstrating a reasonable assurance of safety and effectiveness still applies, according to the agency.
The roots of the prescription opioid overdose crisis in America go back to the late 1990s, when pharmaceutical companies touted prescription painkillers that weren’t supposed to be addictive but actually were. Medical professionals more frequently prescribed opioid painkillers, and opioid-related deaths steadily increased. Tens of thousands of people have been dying annually, according to the Centers for Disease Control and Prevention.
The FDA encouraged applicants who were not selected to interact with the agency through the Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov. DICE will assist in answering questions on U.S. medical device regulation or to direct sponsors to the appropriate premarket review division.
The FDA in recent years has already cleared, granted or approved more than 200 devices to help treat or manage pain; 10 of them involved new or novel technologies including brain and spinal cord stimulators to relieve pain. FDA also recently granted a new indication to an electric stimulation device that could help reduce the symptoms of opioid withdrawal.
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