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Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

Page Type
Product Code
Definition
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 (PTSD).
Physical State
General purpose computing platform (consumer phone and watch) with associated sensors, software, and hardware to provide stimulus
Technical Method
Uses software analysis of heart rate and motion measured during sleep on a general purpose computing platform to apply a stimulus to interrupt a sensed bout of disrupted sleep due to nightmare.
Target Area
Wrist, upper/lower extremities, various locations on the body to sense physiological parameters and apply stimulus
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5705
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5705 Digital therapy device to reduce sleep disturbance for psychiatric conditions

§ 882.5705 Digital therapy device to reduce sleep disturbance for psychiatric conditions.

(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.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing under the labeled conditions for use must evaluate the following:

(i) The ability of the device to provide therapy for patients with sleep disturbance due to psychiatric conditions, using a validated measure;

(ii) Worsening of any condition-specific symptoms using a validated measure for assessment of the particular condition; and

(iii) Increase in symptoms of disturbed sleep or sleepiness using a validated measure.

(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) The labeling must include the following:

(i) Patient and physician labeling must include instructions for use, including images that demonstrate how to interact with the device;

(ii) Patient and physician labeling must list the minimum operating system and general purpose computing requirements that support the software of the device;

(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;

(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

(v) Physician labeling must include a summary of the clinical performance testing conducted with the device.

[88 FR 2223, Jan. 13, 2023]

Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

Page Type
Product Code
Definition
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 (PTSD).
Physical State
General purpose computing platform (consumer phone and watch) with associated sensors, software, and hardware to provide stimulus
Technical Method
Uses software analysis of heart rate and motion measured during sleep on a general purpose computing platform to apply a stimulus to interrupt a sensed bout of disrupted sleep due to nightmare.
Target Area
Wrist, upper/lower extremities, various locations on the body to sense physiological parameters and apply stimulus
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5705
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5705 Digital therapy device to reduce sleep disturbance for psychiatric conditions

§ 882.5705 Digital therapy device to reduce sleep disturbance for psychiatric conditions.

(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.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing under the labeled conditions for use must evaluate the following:

(i) The ability of the device to provide therapy for patients with sleep disturbance due to psychiatric conditions, using a validated measure;

(ii) Worsening of any condition-specific symptoms using a validated measure for assessment of the particular condition; and

(iii) Increase in symptoms of disturbed sleep or sleepiness using a validated measure.

(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) The labeling must include the following:

(i) Patient and physician labeling must include instructions for use, including images that demonstrate how to interact with the device;

(ii) Patient and physician labeling must list the minimum operating system and general purpose computing requirements that support the software of the device;

(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;

(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

(v) Physician labeling must include a summary of the clinical performance testing conducted with the device.

[88 FR 2223, Jan. 13, 2023]