Data / Federal rules / 2026-07861
Medical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia
The Food and Drug Administration published this final rule in the Federal Register on April 22, 2026. It took effect on April 22, 2026.
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What the agency says
The Food and Drug Administration (FDA, the Agency, or we) is classifying the digital therapy device for amblyopia 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 classification of the digital therapy device for amblyopia. We are taking this action because we have determined that classifying the device into class II 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, in part by reducing regulatory burdens.
Key facts
- Document number
- 2026-07861
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- April 22, 2026
- Takes effect
- April 22, 2026
- Dates
- This order is effective April 22, 2026. The classification was applicable on October 20, 2021.
- Docket
- Docket No. FDA-2026-N-3928
- Code of Federal Regulations
- 21 CFR 882
- Topics
- Medical devices; Ophthalmic goods and services
- Pages
- 3
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on medical devices · Rules on ophthalmic goods and services · Published in April 2026
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.