Voglio sapere a riguardo di…

Federal Register / Vol. 86, No. 247 / Wednesday, December 29, 2021 / Rules and Regulations
73975

TABLE 1CEREBROSPINAL FLUID SHUNT SYSTEM RISKS AND MITIGATION MEASURESContinued Identified risks
Mitigation measures
Spinal headache with and without CSF leakage.
Intracranial hemorrhage.
Hematoma e.g., spinal, subdural.
Paraplegia.
Foreign body obstruction.
Procedural/use errors

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510k of the FD&C Act.
At the time of classification, cerebrospinal fluid shunt systems are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502f1 of the FD&C Act 21 U.S.C.
352f1 and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.
III. Analysis of Environmental Impact The Agency has determined under 21
CFR 25.34b that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

khammond on DSKJM1Z7X2PROD with RULES

IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget OMB under the Paperwork Reduction Act of 1995 44 U.S.C. 35013521. The collections of information in the guidance document De Novo Classification Process Evaluation of Automatic Class III Designation have been approved under OMB control number 09100844; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 09100073; the collections of information in 21 CFR part 814, subparts A through E, regarding
VerDate Sep<11>2014

16:59 Dec 28, 2021

Jkt 256001

Labeling.

premarket approval, have been approved under OMB control number 09100231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 09100120; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control number 09100485.
List of Subjects in 21 CFR Part 882
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows:
PART 882NEUROLOGICAL DEVICES
1. The authority citation for part 882
continues to read as follows:

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

2. Add 882.5560 to subpart F to read as follows:

882.5560
system.

Cerebrospinal fluid shunt
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.

PO 00000

Frm 00029

Fmt 4700

Sfmt 9990

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.
Dated: December 17, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202128157 Filed 122821; 8:45 am BILLING CODE 416401P

E:FRFM29DER1.SGM

29DER1