Part 6: FDA Psychiatric Digital Health Guidance | COVID-19


Psychiatric Digital Health Guidance

Navigating the Regulatory Pathway during a Global Pandemic

What are the motivations for the COVID-19 Psychiatric Digital Health guidance?

    • Digital health technologies may improve mental health and well-being of patients with psychiatric conditions during periods of shelter-in-place, isolation, and quarantine.
    • These technologies may facilitate “social distancing” by reducing contact with providers and can ease the burden on health care facilities and professionals experiencing increased demand.

What medical device types are covered by this guidance?

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