---
kind: "section"
citation: "21 C.F.R. § 886.1925"
title: "21"
number: "886.1925"
heading: "Diurnal pattern recorder system."
url: "https://uscodex.org/cfr/21/886.1925"
---

# §886.1925. Diurnal pattern recorder system.

- (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.**

## Notes

### Amendments

[81 FR 34270, May 31, 2016]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

### Amendments

[81 FR 34270, May 31, 2016]