The Food and Drug Administration (FDA) is classifying the strabismus detection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the strabismus detection device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device
The Food and Drug Administration (FDA) is classifying the strabismus detection device into class II (special controls). The special controls that will apply to the device are id...
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81 FR 65279
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“Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device,” thefederalregister.org (September 22, 2016), https://thefederalregister.org/documents/2016-22801/medical-devices-ophthalmic-devices-classification-of-strabismus-detection-device.