Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “FDA: Devs Can Release Digital Products for Psychiatric Disorders Without 510(k) Submission During COVID-19 Crisis,” by Dave Muoio.
Following is an excerpt:
What’s the Impact?
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 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.
