FDA: Devs can release digital products for psychiatric disorders without 510(k) submission during COVID-19 crisis

A new guidance from the U.S. regulator relaxes a handful of requirements for these digital health devices, and clarifies the agency's long-term enforcement policy for low-risk wellness products.
By Dave Muoio
02:38 pm

The FDA released new guidance on digital health devices for treating psychiatric disorders that waives several regulatory requirements – such as need to submit a 510(k) premarket notification – for the duration of the COVID-19 emergency.

"Device availability may increase patient access to digital therapeutics while individuals are following 'stay at home' orders or practicing social distancing, without the need for in-clinic visits during the COVID-19 public health emergency," the agency wrote in the guidance. "Furthermore, increased utilization of digital therapeutic devices may ease burdens on hospitals and other healthcare facilities and reduce the risk of exposure to SARS-CoV-2 for patients and health care providers."

The relaxed requirements apply to what the agency calls "computerized behavioral therapy devices" and other digital health therapeutics for psychiatric disorders (for instance, a prescription app that provides cognitive behavioral therapy to treat major depressive disorder symptoms). For these, the agency listed a handful of regulatory requirements that will temporarily be set aside – so long as the devices "do not create an undue risk."

These waived requirements include: submission of a 510(k) premarket notification, reports of corrections and removals requirements, registration and listing requirements, and unique device identification (UDI) requirements.

The agency is still requiring that products undergo and demonstrate software verification, validation and hazard analysis; meet FDA's requirements for cybersecurity protections; include labeling instructing patients to contact a physician prior to using the device; and prompt users to acknowledge the physician contact recommendation.

These lasting requirements are being kept in place to avoid creating undue risk, the agency wrote. Meanwhile, products claiming to treat psychiatric conditions requiring immediate clinical intervention – such as a digital treatment for suicidality – would be creating an undue risk and do not fall under the new policy.

In addition to the relaxed requirements, the FDA's new document provides more clarity on enforcement policy for "low-risk general wellness" products addressing psychiatric health.

Here, the agency provided examples of products that would or would not be considered a medical device per the Federal Food, Drug and Cosmetic Act, as well as software functions that might meet the definition of a device but are not being overseen by the regulator. Some examples of the latter include software with functions like a psychiatric symptom checklist, or those that help users self-manage a condition without providing specific treatment or treatment suggestions.


Extended periods of isolation will take a mental toll on anyone, and those who have already been diagnosed with a psychiatric condition are at an even greater risk throughout the COVID-19 emergency. Much like its prior COVID-19 guidances, yesterday's policy update looks to increase the public's access to lower-risk digital health tools at a time when their need is greatest.

"The FDA seems to be motivated by the fact that the primary risk of these devices ... comes from potential ineffectiveness," Epstein, Becker and Green's Bradley Merrill Thompson, who counsels on the regulation of medical devices and related products, told MobiHealthNews. "And so, during this extreme situation where demand for mental health services is dramatically outstripping supply, FDA is willing to bypass its normal regulatory requirements. That is a very practical reaction."

Thompson (who noted that he currently represents "quite a few" developers of psychiatric disorder apps) was largely in favor of both the temporarily relaxed requirements and the longer-term wellness product clarifications. For the former, he said that the requirements that do remain in place will be time consuming enough to prevent companies from using the ongoing emergency to create and release a brand new product from scratch.

On the other hand, Thompson said that companies in a position to take advantage of the policy should worry about whether temporary launch of their treatment might introduce new difficulties when the grace period is over.

"What will FDA expect when they lift the emergency? Will they expect companies to go and rip these products out of patients' hands? The silence in the document would suggest so," he said. "Maybe FDA is just saying they will deal with that eventuality when it comes. But I think FDA owes companies some transparency about its intentions of what will happen. Someday this too shall pass. But companies need to know what will be expected of them when it does."

As per the wellness guidance update, Thompson said that these clarifications generally appear to expand the number of digital health products that won't require the regulator's attention.


From testing to treatments, the FDA has been overhauling a number of its standard practices in light of the COVID-19 emergency. On March 20 the agency expanded the use of connected, non-invasive remote vital-sign monitors to enable more out-of-hospital care. Just the other week it released a similar policy for remote ophthalmic assessment and monitoring devices.

And the regulator is hardly the only federal organization that's working to expand access to digital and connected health tools. CMS has temporarily expanded telehealth benefits, the FCC is bankrolling major investments in telehealth infrastructure and the Department of Veterans Affairs has placed telehealth at the core of its COVID-19 Response Plan.


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