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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Mar 22, 2024.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR882.5560]
See Related Information on Cerebrospinal fluid shunt system. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 882 -- NEUROLOGICAL DEVICES

Subpart F - Neurological Therapeutic Devices

Sec. 882.5560 Cerebrospinal fluid shunt system.

(a) Identification. A cerebrospinal fluid shunt system is a prescription device used to monitor and divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of preventing spinal cord ischemia or injury during procedures that require reduction in central nervous system pressure. A cerebrospinal fluid shunt system may include catheters, valved catheters, valves, connectors, and pressure monitors intended to facilitate use of the shunt or evaluation of a patient with a shunt.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The device description must include a detailed summary of the device technical parameters, including design configuration, dimensions, engineering drawings, and a list of all components with identification of their materials of construction.

(2) The patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Simulated use testing must be conducted to characterize fluid flow and resistance to leakage; and

(ii) Mechanical integrity testing of all connections must be conducted.

(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf life.

(5) Performance data must demonstrate the sterility and pyrogenicity of patient-contacting components of the device.

(6) The labeling must include:

(i) Contraindications with respect to patients who should not receive a lumbar drain;

(ii) A warning that the device should have 24-hour-a-day availability of trained personnel to supervise monitoring and drainage;

(iii) Instructions on proper device setup, positioning, and monitoring;

(iv) Warnings and precautions to inform the user of serious hazards and special care associated with the use of the device;

(v) A statement that the device is not to be reused, reprocessed, or resterilized when open but unused; and

(vi) Cleaning instructions for the injection sites.

[86 FR 73975, Dec. 29, 2021]

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