FDA innovation challenge for development of medical devices for opioid crisis
The challenge will result in new medtech including digital health technologies and diagnostic tests to help detect, treat and prevent overuse and abuse of opioids.
The U.S Food and Drug Administration is responsible for protecting the public health by assuring the safety, efficacy, and security of human. FDA truly believes that opioid addiction/abuse is an immense public health crisis. Opioids are substances that act on opioid receptors in order to produce morphine-like effects. In medical terms, opioids are primarily used for pain relief, including anaesthesia.
To combat the opioid crisis, FDA announced innovation challenge to encourage the development of medical devices to help reduce the country’s opioid abuse crisis.
This challenge will spur the development of new medical devices that will be responsible for diagnosis that could help in treating the pain as well as preventing addiction to such drugs.
FDA Commissioner Scott Gottlieb, M.D. said, “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.”
He further said, “For example, better medical devices that can effectively address local pain syndromes can, in some cases, supplant the use of systemic opioids. This can help reduce overall use of opioids. This innovation challenge is an example of the FDA’s commitment to an all-of-the-above approach to confronting the opioid epidemic, including helping those currently addicted to opioids and preventing new cases of addiction.”
FDA is hopeful that by by 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 a novel and effective ways to help reduce the scope of this crisis.”
The innovation challenge is very interesting as it is open to developers of currently marketed devices who are keen to demonstrate an improved benefit-risk profile for their devices.
Apart from this, products that are in concept and testing phase are allowed to participate in this challenge. FDA is willing to accept submissions this year from early June till September 30. However, they are planning to announce shortlisted applicants in November when the FDA’s Center for Devices and Radiological Health evaluates the applications based on feasibility, potential public health impact, and novelty of the concept.
In the past, FDA approved around 200 devices in order to treat pain, out of which 10 devices were focusing on new technologies including spinal cord stimulators and brain to relieve pain. FDA also recently granted a new indication to an electric stimulation device that could eventually reduce the symptoms of opioid withdrawal.
FDA is seeking proposal submissions that include treatments, eliminating the need for opioid-derived analgesics and products that undergo identification and risk evaluation tests.
Submissions also include therapies for the symptoms of opioid use disorder and withdrawal. It will also include products that can be used to prevent the diversion of prescriptions. Selected applicants will receive heightened interaction with the agency during the process of development. Moreover, those products that are accepted will be given breakthrough Device designation.
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