21 CFR §882.5705

1. (a)Identification. A digital therapy device to reduce sleep disturbance for psychiatric conditions is a prescription device that is intended to provide stimulation using a general purpose computing platform to reduce sleep disturbance in patients who experience this symptom due to psychiatric conditions such as nightmare disorder or post-traumatic stress disorder.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)Clinical performance testing under the labeled conditions for use must evaluate the following:
      1. (i)The ability of the device to provide therapy for patients with sleep disturbance due to psychiatric conditions, using a validated measure;
      2. (ii)Worsening of any condition-specific symptoms using a validated measure for assessment of the particular condition; and
      3. (iii)Increase in symptoms of disturbed sleep or sleepiness using a validated measure.
   2. (2)Software must clearly describe all features and functions of the software implementing the digital therapy. Software verification, validation, and hazard analysis must also be provided.
   3. (3)The labeling must include the following:
      1. (i)Patient and physician labeling must include instructions for use, including images that demonstrate how to interact with the device;
      2. (ii)Patient and physician labeling must list the minimum operating system and general purpose computing requirements that support the software of the device;
      3. (iii)Patient and physician labeling must include a warning that the digital therapy device is not intended for use as a stand-alone therapeutic device;
      4. (iv)Patient and physician labeling must include a warning that the digital therapy device does not represent a substitution for the patient's medication; and
      5. (v)Physician labeling must include a summary of the clinical performance testing conducted with the device.