According to the FD&C Act, FDA continuously collects market updates and adopts recommendations to modify the classification policy and to match the market and technology requirements.
FDA received the De Novo Classification request to re-classify the devices [1, 2 as below]. Finally, in January 2023, the new order effective for the modification of the Classification of the Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions [1] and the Prognostic Test for Assessment of Liver Related Disease Progression [2] has been implemented, determining a classification as Class II.

The Digital Therapy Device to Reduce Sleep Disturbance for Psychiatric Conditions:
US FDA has identified the risks in the following table 1, and provides suggestions mitigating these risks of the Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions:

Table 1, FDA summarizes the Risks and Mitigation Measures [1]

Identified Risks	Mitigation Measures
Ineffective treatment leading to worsening sleep.	Clinical performance testing.
Ineffective treatment leading to worsening condition-specific symptoms.	Clinical performance testing.
Device software failure leading to delayed access and treatment.	Software verification, validation, and hazard analysis.
Improper device use leading to worsening sleep.	Labeling.

For more detailed information, you may search Regulation Number 882.5705 to refer to the complete FDA requirements for the device [3].

The Prognostic Test for Assessment of Liver Related Disease Progression:
US FDA has likewise identified the risks in the following table 1, and provides suggestions mitigating these risks of the Prognostic Test for Assessment of Liver Related Disease Progression:

Table 2, FDA summarizes the Risks and Mitigation Measures [2]

Identified Risks	Mitigation Measures
False negative results leading to delayed assessment or treatment.	Design verification and validation activities, including certain clinical studies; and certain labeling information, as well as specific warnings and performance information.
False positive results leading to unnecessary medical procedures.	Design verification and validation activities, including certain clinical studies; and certain labeling information, including specific warnings and performance information.

For further detailed information, please search and refer to the Regulation Number 862.1622 to see the complete FDA requirements for the device [4].

 

 

References:

1. Medical Devices; Neurological Devices; Classification of the Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions
2. Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Liver Related Disease Progression
3. 882.5705 Digital therapy device to reduce sleep disturbance for psychiatric conditions
4. 862.1622 Prognostic test for assessment of liver related disease progression.