federal_register: 2016-12683

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2016-12683 Medical Devices; Ophthalmic Devices; Classification of the Diurnal Pattern Recorder System Rule The Food and Drug Administration (FDA) is classifying the diurnal pattern recorder system 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 diurnal pattern recorder system'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. 2016-05-31 2016 5 https://www.federalregister.gov/documents/2016/05/31/2016-12683/medical-devices-ophthalmic-devices-classification-of-the-diurnal-pattern-recorder-system https://www.govinfo.gov/content/pkg/FR-2016-05-31/pdf/2016-12683.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is classifying the diurnal pattern recorder system 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...

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