The Food and Drug Administration (FDA) is classifying the nasolacrimal compression device into class I (general controls). The Agency is classifying the device into class I (general 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 Nasolacrimal Compression Device
The Food and Drug Administration (FDA) is classifying the nasolacrimal compression device into class I (general controls). The Agency is classifying the device into class I (gen...
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81 FR 37499
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“Medical Devices; Ophthalmic Devices; Classification of Nasolacrimal Compression Device,” thefederalregister.org (June 10, 2016), https://thefederalregister.org/documents/2016-13788/medical-devices-ophthalmic-devices-classification-of-nasolacrimal-compression-device.