FDA Approves First-Ever Mobile App for Addiction Treatment
The FDA recently approved the marketing of the first-ever prescription digital therapeutic to be used in the treatment of substance use disorder (SUD).
The reSET® mobile app, developed by Pear Therapeutics, is approved to assist individuals undergoing outpatient therapy for alcohol, cocaine, marijuana, and stimulant addictions. The application is not intended for use in treating opioid dependence, however.
The reSET® application is designed to provide a form of treatment called cognitive behavioral therapy. It teaches SUD patients practical skills that help them abstain from using drugs and stick with their rehab programs, and provides a series of reward-based incentives. reSET® is not approved as a standalone treatment. Instead, it is designed to be used in conjunction with outpatient addiction therapy.
“This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment,” said Carlos Peña, Ph.D., M.S., director of the Division of Neurological and Physical Medicine Devices in FDA’s Center for Devices and Radiological Health. “More therapy tools means a greater potential to improve outcomes, including abstinence, for patients with substance use disorder.”
reSET® was reviewed through the FDA’s de novo premarket review pathway, a regulatory scheme for low- to moderate-risk devices for which there is no legally marketed predicate to which the device can claim substantial equivalence. The FDA reviewed data from a multi-site, unblinded 12-week clinical trial of 399 patients. In this trial, patients with alcohol, cocaine, marijuana, and stimulant SUD who used reSET® demonstrated statistically significant greater adherence to abstinence (40.3 percent) compared to patients not using reSET® (17.6 percent).
Corey McCann, President and CEO of Pear Therapeutics stated in a company press release:
We believe that prescription digital therapeutics hold promise in improving patient outcomes across a wide range of central nervous system disorders including psychiatry, neurology and pain, and will become a vital part of tomorrow’s treatment paradigm across all disease areas.
Regulatory approval of reSET® may represent an important step forward in the use of mobile applications to treat people with psychological, neurological and substance abuse disorders.
FDA Issues Proposed Guidance for Changes to Medical Device Software
The U.S. Food & Drug Administration (FDA) issued a proposed guidance on August 8, 2016, regarding software changes to medical devices. The proposed guidance relates to requirements for submitting medical device software changes to the FDA for approval. The final document will provide assistance to medical device companies and the FDA for determining when changes to software or firmware for a medical device require FDA clearance. The medical devices covered include 510(k)-cleared devices and preamendments devices subject to 510(k).
The FDA’s proposed guidance explains that premarket notifications are generally submitted for commercially-distributed medical devices undergoing significant changes in design. Such changes include modifications that “could significantly affect the safety or effectiveness of the device” or a “major change or modification in the intended use of the device.” The proposed guidance relates to software changes and is an update to the original guidance issued in 1997 regarding changes to existing devices.
The “software” subject to the proposed guidance is defined as “electronic instructions used to control the actions or output of a medical device, to provide input to or output from a medical device, or to provide the actions of a medical device.” This includes software embedded in a device, software that is an accessory to another device, and “software that is intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device.”
The FDA provides a flow chart for assisting with the determination, see below. Issues addressed in the determination include changes related to: strengthening cyber security; meeting specifications of the most recently cleared device; introducing or affecting hazardous situations; creating new risk control measures; and affecting clinical functionality or intended use of the device. Additional factors to consider beyond those in the flow chart and some examples of modifications are provided in the draft guidance as well.
The proposed guidance notes that in some cases a new 510(k) is not necessary, and that existing Quality System (QS) requirements may suffice. Such QS requirements mandate, among other things, that the manufacturer maintains records, for production upon request, regarding such changes and the processes used to determine the changed device meet the design specifications. Further, the proposed guidance does not apply to software for which the FDA has previously said it will not enforce compliance, including some mobile apps used with medical devices.
Some observers think the proposed guidance will help with improving cybersecurity of connected medical devices. The public may provide comments to the FDA on the proposed guidance until November 7, 2016: comments may be submitted electronically here.
FDA Releases Guidance on Medical Apps
There seems to be a mobile app for just about everything now. Among the multitude of apps available are an increasing number of medical apps. In response to this growing trend, the FDA has issued a final guidance document for developers of mobile medical apps. The guidance explains that the FDA plans to limit its scrutiny to apps that transform a mobile device into a regulated medical device or are intended to be used as an accessory to a regulated medical device because these types of apps could be harmful if they don’t function properly.
The final document follows a draft issued in July 2011 that received more than 130 comments. In response to comments seeking more clarity, the FDA included in the final version more examples of what the agency does and does not intend to regulate. According to the guidance document, examples of apps that will be the subject of oversight include apps that calculate the amount of radiation to be given to a cancer patient and apps that control inflation and deflation of a blood pressure cuff. The guidance indicates that these types of apps essentially perform the functions of traditional medical devices, and notes that the FDA will regulate them as it does traditional devices.
According to the guidance document, the agency plans to leave low-risk apps alone, even those that might fall under the definition of a medical device. For example, apps that allow doctors or patients to log blood pressure readings or diet related apps that recommend the number of calories a person should consume may not be scrutinized. The guidance document also clarifies that providers of medical apps, for example, the iTunes app store, will not be treated as medical device manufacturers.
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