Data / Federal rules / 2024-19720
Medical Devices; Neurological Devices; Classification of the Digital Therapy Device for Attention Deficit Hyperactivity Disorder
The Food and Drug Administration published this final rule in the Federal Register on September 3, 2024. It took effect on September 3, 2024.
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What the agency says
The Food and Drug Administration (FDA or we) is classifying the digital therapy device for Attention Deficit Hyperactivity Disorder into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the digital therapy device for Attention Deficit Hyperactivity Disorder's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Key facts
- Document number
- 2024-19720
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- September 3, 2024
- Takes effect
- September 3, 2024
- Dates
- This order is effective September 3, 2024. The classification was applicable on June 15, 2020.
- Docket
- Docket No. FDA-2024-N-3992
- Code of Federal Regulations
- 21 CFR 882
- Topics
- Medical devices
- Pages
- 2
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on medical devices · Published in September 2024
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.