In MedTech Dive, Kellie Combs Examines FDA Guidance on Digital Health Devices for Treating Psychiatric Disorders
In a MedTech Dive article, FDA regulatory partner Kellie Combs (Washington, D.C.) analyzes recent U.S. Food and Drug Administration guidance on digital health devices for treating psychiatric disorders.
During the COVID-19 pandemic, FDA temporarily lowered some barriers — including the necessity for 510(k) medical device submissions, certain clinical evidence standards, and registration and listing requirements — for low-risk technologies that could provide relief to individuals with anxiety, depression, insomnia, ADHD, PTSD and autism, among other psychiatric disorders. The FDA asserts the policy will not create undue risk for products that are validated, follow cybersecurity best practices, and instruct the user to consult a doctor before using the device.
Kellie explains that if and when the FDA starts enforcing the various regulatory requirements for the digital health tools, the digital therapeutic developers will be well positioned to make an FDA submission that would comply with the more formal regulatory requirements.