WASHINGTON, April 22 -- Food and Drug Administration has issued a rule called: Medical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia.
The rule was published in the Federal Register on April 22 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: 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 devi...