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

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...

More from Digital Technologies

More from Medtech Insight

Court Orders US FDA To Return Trial Diversity Action Plan Guidance To Website

 
• By 

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Planning To Take Part in MDUFA? FDA Wants To Hear From You

 

The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.

Global Medtech Guidance Tracker: June 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.