Here are three insights:
1. In May, the FDA unveiled a program to award innovative devices breakthrough device designation, which would enable them to bring products to market sooner.
2. Medical devices in any stage of development can be submitted, including ones on the market.
3. The FDA will announce the winners in November.
“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 May 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.”
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