contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Identification. A diurnal pattern recorder system is a nonimplantable, prescription device incorporating a telemetric sensor to detect changes in ocular dimension for monitoring diurnal patterns of intraocular pressure (IOP) fluctuations.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)Clinical performance data must demonstrate that the device and all of its components perform as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:
(i)Ability of the device to detect diurnal changes.
(ii)Tolerability of the system at the corneoscleral interface in the intended use population.
(2)Nonclinical testing must validate measurements in an appropriate nonclinical testing model to ensure ability to detect changes in intraocular pressure.
(3)Patient-contacting components must be demonstrated to be biocompatible.
(4)Any component that is intended to contact the eye must be demonstrated to be sterile throughout its intended shelf life.
(5)Software verification, validation, and hazard analysis must be performed.
(6)Performance testing must demonstrate the electromagnetic compatibility and electromagnetic interference of the device.
(7)Performance testing must demonstrate electrical safety of the device.