FDA Guidelines Temporarily Expand Access To Low-Risk mHealth & Telemental Health Devices
On April 14, 2020, the U.S. Food and Drug Administration (FDA) issued guidance that temporarily expands availability of digital health devices intended to aid treatment for metal heath disorders. The FDA reduced regulatory barriers on devices it believes pose low risk of harm to users. The goal is to expand the availability of these devices while reducing user and health care professional contact and potential exposure to COVID-19 during the pandemic.
The FDA defines software functions as “devices” when the functions …
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