USA: US Medical Device Classification Update: Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions & The Prognostic Test for Assessment of Liver Related Disease Progression – February/March 2023
- 2023-02-22 11:03:38
According to US FDA's review request for devices, the digital therapy device to reduce sleep disturbance for psychiatric conditions, and the prognostic tests for assessment of liver-related disease progression, will require special control (Class II). Thus, in the future, the US FDA will refer to the class II level to review these two kinds of devices.
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