Federal Register: Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device

The 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 cla...
Source: Food and Drug Adminstration (FDA): CDRHNew - Category: Medical Equipment Source Type: news