Skip to main content
Find a Lawyer

Code of Federal Regulations Title 21. Food and Drugs § 21.886.1925 Diurnal pattern recorder system

Current as of January 02, 2025 | Updated by Findlaw Staff

(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.

Previous Part of Code Next Part of Code
Back to Chapter List

Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.886.1925 Diurnal pattern recorder system - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-886-1925/

FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature before relying on it for your legal needs.

Was this helpful?

Welcome to FindLaw's Cases & Codes

A free source of state and federal court opinions, state laws, and the United States Code. For more information about the legal concepts addressed by these cases and statutes, visit FindLaw’s Learn About the Law.

Go to Learn About the Law

Latest Blog Posts

For Legal Professionals

Learn About The Law

Get help with your legal needs

FindLaw’s Learn About the Law features thousands of informational articles to help you understand your options. And if you’re ready to hire an attorney, find one in your area who can help.

Go to Learn About the Law

Need to Find an Attorney?

Search our directory by legal issue

Enter information in one or both fields (Required)

Copied to clipboard