FDA Wants More Medical Devices to Treat Pain
Wearable Pain Relief Technology
The deadline is fast approaching for companies to enter the Food and Drug Administration’s medical device challenge, a contest of sorts aimed at stimulating the development of new technologies to treat pain and prevent opioid abuse.
The FDA announced the innovation program in May and the deadline for applications is September 30. Medical devices in any state of development – including those already on the market – are eligible for submission.
“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,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “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.”
Devices that are found to innovative will receive a “breakthrough device” designation from the FDA – similar to the “fast track” designation that the agency gives to promising pharmaceutical drugs. With fewer regulatory hurdles, companies can bring their products to the market sooner.
“I think its great. It’s exactly the kind of thing that’s needed,” said Shai Gozani, MD, President and CEO of NeuroMetrix, the maker of Quell. “It’s a little unclear what exactly they’ll offer to the winners. It looks like they’ll give you intensive help for a period of time to climb the regulatory pathway.”
In recent years, the FDA has granted or approved over 200 devices related to the treatment and management of pain. One of them was Quell – a nerve stimulation device worn just below the knee – that relieves pain without drugs in patients suffering from arthritis, neuropathy, fibromyalgia and other chronic conditions. Since its release in 2015, over 150,000 Quell devices have been shipped.
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