Medical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Issuing agencies
Abstract
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.
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