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Opioid Use Disorder App Marks A Path For 510(k) 'Breakthrough' Devices

 
• By David Filmore

Pear Therapeutics announced US Expedited Access Pathway designation earlier this month for its 510(k)-route reSET-O Prescription Digital Therapeutic for OUD, perhaps providing some insight into the types of products seeking a "substantial equivalence" claim that might, nonetheless, be considered breakthroughs.

A heavily studied mobile medical app intended to support treatment of opioid use disorder (OUD) is among the first 510(k)-route products to gain entry into US FDA's Breakthrough Devices Program, providing some insight into the types of products that might be considered breakthroughs even though they are seeking a "substantial equivalence" claim to something already on the market.

Pear Therapeutics announced Expedited Access Pathway designation earlier this month for its reSET-O Prescription Digital Therapeutic for OUD. FDA has recently started to refer to the 2015-launch EAP program as the Breakthrough Devices Program to align with a provision of the 21st Century Cures Act that updates the program. The agency issued a draft guidance Oct. 24 on the updated program, which offers an expedited development route for devices that may address an unmet need for life-threatening or irreversibly debilitating diseases or conditions

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