The FDA and Digital Therapeutics in the Era of COVID-19

In 2020, the impact of COVID-19 was painstakingly apparent. In addition to affecting people’s physical health, the virus also contributed to a marked increase in mental health problems. Those who were mentally sound began to experience anxiety, depression, and a plethora of other mental issues due to the loss of loved ones, a fear of infection, and prolonged isolation.

Though the number of in-person mental health office appointments declined considerably to slow the spread, mental health care demand continued to grow exponentially. To meet the behavioral health needs of the public, healthcare providers and government entities began to search for new ways to make healthcare more accessible during the COVID crisis. The answer was making DTx available to those in need of help for non-life-threatening mental health conditions. Let’s explore the FDA policy that changed the landscape of DTx for behavioral health.

A New Policy for Digital Health Devices

Health authorities decided to tackle the ongoing mental health crisis by digitalizing healthcare services. The goal was to allow patients to receive care remotely, reducing their risk of contracting or spreading COVID-19. After all, patients still needed access to mental illness treatments- pandemic or no pandemic.

For this reason, in April 2020, the Food and Drug Administration (FDA) officially released a new policy governing the requirements to bring new digital health devices to market, including those intended for the treatment of behavioral health disorders. It waived certain regulatory requirements, such as the submission of 510(k) premarket notifications, for the duration of the COVID-19 emergency. The policy aimed to knock down barriers preventing DTx developers from developing medical interventions, thus making digital health devices more widely available.


The FDA policy targeted two main groups of digital products:

  1. Computerized systems aimed at diagnosing psychiatric disorders and suggesting behavioral therapies through digital devices.
  2. Low-risk wellness products to be used for psychiatric conditions that do not require an in-person doctor visit.


Some of the psychiatric conditions that are relevant to this policy include:

  • Major Depressive Disorder
  • Attention Deficit Hyperactivity Disorder
  • Insomnia Disorder
  • Generalized Anxiety Disorder
  • Autism Spectrum Disorder
  • Post-Traumatic Stress Disorder

Note: This is not an exhaustive list.

Impact Of FDA Regulations on Digital Therapeutics

Due to the FDA’s “relaxed requirements,” developers worldwide are quickly creating and marketing new medical interventions to treat, manage, or improve mental health disorders. Moreover, medical practices, facilities, organizations, and patients have easy access to digital therapeutics for remote mental health care.

And, even as COVID-19 is losing steam in the U.S., these DTx apps and programs are still very widely used.

What Does the Future Hold for Digital Therapeutics?

The FDA has been planning the development of digital health products since 2017 by implementing health solutions that satisfy general wellness requirements such as providing therapy, screening and diagnosing diseases, and estimating prognoses. This indicates that the FDA respects and favors digital therapeutics. But does this mean that digital therapeutics are here to stay?

Not necessarily. However, the merit of evidence-based digital mental health care is promising. First, being able to access evidence-based mental health care on your phone or tablet is convenient. Moreover, devices developed in conjunction with medical professionals, caregivers, and patients themselves could create a tailored experience that is both safe and effective. In addition, DTx have extremely broad applications, meaning they could be used to diagnose, treat, and manage a variety of mental health conditions.

Digital therapeutics in general get more popular every day, and mental health devices are no exception. It will be critically important that such devices are appropriately tested to ensure efficacy and safety.

Will the FDA Regulation Be Repealed?

As of the time of this writing, there is no sign that FDA regulations on digital therapeutics will be repealed. In fact, in the coming months, we may see the regulations become permanent.

According to the Federal Register published in January 2021, the FDA requested research, analysis, and public comment to determine whether they should permanently exempt certain medical devices from the 510(k) requirement. No action has been taken to make the exemption permanent as of yet, but the possibility remains.

On the other hand, some believe that President Biden will push for more regulations on mental health DTx in the future, stating that the President wants to undo Ex-president Trump’s regulations. But this has not been confirmed by the President himself.

There is a ton of speculation around this subject, but only time will tell what the future holds.

Concluding Remarks

The COVID-19 pandemic was a strong catalyst for the shift toward digital therapeutics for mental health, being that it led to widespread mental issues among individuals of all ages. In fact, one of the very few positive outcomes of the pandemic is that it very quickly advanced the digitalization of mental health treatments and therapies. The FDA policy opened the doors for the development and sale of groundbreaking new mental health technologies, making it easier for patients to find care for certain mental health conditions.

Although we are all curious about the future, we can all agree that, whether or not the FDA decides to repeal the policy and reinstate the 510(k) requirement, digital therapeutics are here to stay.

Researchers interested in using technology to develop and test digital health treatments to determine whether they are safe and effective for end-users can visit Colliga IO.

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