Mid-Atlantic Health Law TOPICS

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FDA Clears First Digital Therapeutic Device

In September, Pear Therapeutics received clearance from the Food and Drug Administration (FDA) to market the reSET® mobile medical application. The reSET app is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana and other substance abuse disorders involving stimulants. This is the first time that the FDA has cleared a prescription digital therapeutic with claims to improve clinical outcomes in a disease.

A.  The reSET App

The reSET app includes an interface accessible by patients and a dashboard for clinicians. Patients interact with the app to learn skills that aid in the treatment of substance abuse disorders. The reSET app is designed to be used in conjunction with outpatient therapy and a contingency management system that rewards patients for adherence to their treatment programs.

B.  Clinical Trials

In a multi-site, unblinded, 12-week clinical trial of 399 patients who received either standard face-to-face counseling or standard face-to-face counseling in conjunction with the reSET app, the patients that used the reSET app experienced statistically significant abstinence from the use of alcohol, cocaine, marijuana and stimulants. Overall, 40.3% of patients that used the reSET app abstained, compared to 17.6% who did not. The clinical trial did not demonstrate effectiveness in patients reporting opioids as their substance of abuse.

C.  De Novo Premarket Review

The FDA reviewed the reSET app through its de novo premarket review pathway. The de novo pathway allows for the clearance of medical devices for which no substantially equivalent device exists in the marketplace. Under the de novo pathway, novel medical devices may be classified as class I (low risk) or class II (moderate risk), without requiring the device sponsor to deliver a very costly premarket notification (510(k)) submission to the FDA that pertains to safety and effectiveness.

Thede novo pathway (and perhaps eventually the FDA’s nascent Software Precertification Program) may become an increasingly attractive option as a progressively wider array of digital technologies, such as wearable robotics and artificial intelligence, integrate into the medical device space.


Ned T. Himmelrich
410-576-4171 • nhimmelrich@gfrlaw.com