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FDA Clears Prescription Mobile Medical App for Opioid Use Disorder

December 11, 2018

On December 10, 2018, the Food and Drug Administration (FDA) granted 510(k) clearance to reSET-O (Pear Therapeutics), a prescription mobile medical application (app) to help adults with opioid use disorder (OUD) remain in their recovery programs.

The reSET-O app can be downloaded directly to the patient’s mobile device after receiving a prescription. It is indicated to increase retention of patients with OUD in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. The app has not been shown to decrease illicit drug use or improve abstinence in patients with OUD.

Last month, Pear Therapeutics launched the reSET prescription mobile medical app to help treat substance use disorders (SUD). The FDA cleared this app for market through the de novo premarket review pathway. The company plans to launch the reSET-O app within the next few days.


Food and Drug Administration (FDA). FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs [news release]. December 10, 2018. Available at: click here. Accessed December 10, 2018.