Federal Register #2026-07861

FDA Classifies Digital Therapy Device for Amblyopia and Sleep Apnea Testing Device as Class II with Special Controls

This notice announces the FDA's final order classifying two medical devices as Class II with special controls: - Government Buyer: - Food and Drug Administration (FDA), Center for Devices and Radiological Health - Devices Classified: - Digital therapy device for amblyopia (notably, Luminopia One by Luminopia, Inc.) - Uses dichoptic presentations on visual displays with therapeutic algorithms to treat amblyopia or improve visual acuity - Requires: - Clinical performance testing - Software verification and validation - Non-clinical performance testing - Compatibility testing with visual displays - Labeling with minimum hardware/OS requirements, compatible display models, treatment duration, and clinical testing summaries - Labeling comprehension testing - Device for sleep apnea testing based on mandibular movement - Prescription device to aid in evaluating sleep apnea by analyzing mandibular movement during sleep - Requires: - Clinical data - Biocompatibility and performance data - Software validation - Specific labeling - OEMs and Vendors: - Luminopia, Inc. (referenced as De Novo requester for Luminopia One) - Unique Requirements: - Both devices require premarket notification under section 510(k) - Special controls are intended to ensure safety and effectiveness while facilitating patient access to innovative devices - No procurement or solicitation for products or services is involved; this is a regulatory classification action.

Description

The Food and Drug Administration (FDA) is classifying the digital therapy device for amblyopia into class II with special controls to ensure safety and effectiveness. This classification aims to provide reasonable assurance of safety and effectiveness while enhancing patient access to innovative devices by reducing regulatory burdens. The device incorporates dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or improve visual acuity. The classification includes requirements for clinical performance testing, software verification and validation, non-clinical performance testing, and specific labeling requirements.

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