2024-19720. Medical Devices; Neurological Devices; Classification of the Digital Therapy Device for Attention Deficit Hyperactivity Disorder

Table 1—Digital Therapy Device for Attention Deficit Hyperactivity Disorder Risks and Mitigation Measures

Identified risks to health	Mitigation measures
Ineffective treatment leading to worsening or uncontrolled symptoms	Clinical performance testing, and Labeling.
Device software failure leading to delayed access	Software verification and validation, and Labeling.
Treatment results in frustration, emotional reaction, dizziness, nausea, headache, eye-strain, or joint pain	Labeling; Clinical performance testing; and Software verification, validation, and hazard analysis.
Treatment results in seizure	Labeling, and Clinical performance testing.
Treatment results in screen addiction	Labeling, and Clinical performance testing.
Treatment results in decreased sleep quality	Labeling, and Clinical performance testing.