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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.
(8) Labeling must include the following:
(i) Warning against activities and environments that may put the user at greater risk.
(ii) Specific instructions for the safe use of the device, which includes:
(A) Description of all device components and instructions for assembling the device;
(B) Explanations of all available programs and instructions for their use;
(C) Instructions and explanation of all user-interface components;
(D) Instructions on all safety features of the device; and
(E) Instructions for properly maintaining the device.
(iii) A summary of nonclinical testing information to describe EMC safety considerations.
(iv) A summary of safety information obtained from clinical testing.
(v) Patient labeling to convey information regarding appropriate use of device.
[81 FR 34270, May 31, 2016]
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