Document ID: FDA-2021-N-0855-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Neurological
Devices; Classification of the
Cerebrospinal Fluid Shunt System
Posted Date: 2021-12-29T05:00Z

[Federal Register Volume 86, Number 247 (Wednesday, December 29, 2021)]
[Rules and Regulations]
[Pages 73973-73975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28157]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2021-N-0855]

Medical Devices; Neurological Devices; Classification of the 
Cerebrospinal Fluid Shunt System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the cerebrospinal fluid shunt system into class II (special controls). 
The special controls that apply to the device type are identified in 
this order and will be part of the codified language for the 
cerebrospinal fluid shunt system's classification. We are taking this 
action because we have determined that classifying the device into 
class II (special controls) will provide a reasonable assurance of 
safety and effectiveness of the device. We believe this action will 
also enhance patients' access to beneficial innovative devices.

DATES: This order is effective December 29, 2021. The classification 
was applicable on August 22, 2014.

FOR FURTHER INFORMATION CONTACT: Xiaolin Zheng, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2674, Silver Spring, MD 20993-0002, 301-796-2823, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the cerebrospinal fluid shunt 
system as class II (special controls), which we have determined will 
provide a reasonable assurance of safety and effectiveness. In 
addition, we believe this action will enhance patients' access to 
beneficial innovation.

[[Page 73974]]

    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified as, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (see 21 U.S.C. 
360c(f)(1)). We refer to these devices as ``postamendments devices'' 
because they were not in commercial distribution prior to the date of 
enactment of the Medical Device Amendments of 1976, which amended the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that 
does not require premarket approval. We determine whether a new device 
is substantially equivalent to a predicate by means of the procedures 
for premarket notification under section 510(k) of the FD&C Act (21 
U.S.C. 360(k) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). A device sponsor may 
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device 
that has not previously been classified. After receiving an order from 
FDA classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person then requests a classification under section 
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required 
to classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act. Although the device was automatically placed 
within class III, the De Novo classification is considered to be the 
initial classification of the device.
    We believe this De Novo classification will enhance patients' 
access to beneficial innovation. When FDA classifies a device into 
class I or II via the De Novo process, the device can serve as a 
predicate for future devices of that type, including for 510(k)s (see 
section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device 
sponsors do not have to submit a De Novo request or premarket approval 
application to market a substantially equivalent device (see section 
513(i) of the FD&C Act, defining ``substantial equivalence''). Instead, 
sponsors can use the less-burdensome 510(k) process, when necessary, to 
market their device.

II. De Novo Classification

    For this device, FDA issued an order on November 27, 2012, finding 
the Medtronic DUETTM External Drainage and Monitoring System 
(EDMS) not substantially equivalent to a predicate device and not 
subject to a premarket approval application (PMA). Thus, the device 
remained in class III in accordance with section 513(f)(1) of the FD&C 
Act when we issued the order.
    On December 21, 2012, FDA received Medtronic Neurosurgery's request 
for De Novo classification of the Medtronic DUETTM EDMS. FDA 
reviewed the request in order to classify the device under the criteria 
for classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves 
are insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls that, in combination with the general controls, provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (see section 513 (a)(1)(B) of the FD&C Act). After 
review of the information submitted in the request, we determined that 
the device can be classified into class II with the establishment of 
special controls. FDA has determined that these special controls, in 
addition to the general controls, will provide reasonable assurance of 
the safety and effectiveness of the device.
    Therefore, on August 22, 2014, FDA issued an order to the requester 
classifying the device into class II. In this final order, FDA is 
codifying the classification of the device by adding 21 CFR 
882.5560.\1\ We have named the generic type of device cerebrospinal 
fluid shunt system, and it is identified as 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.
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    \1\ FDA notes that the ACTION caption for this final order is 
styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
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    FDA has identified the following risks to health associated 
specifically with this type of device and the measures required to 
mitigate these risks in table 1.

 Table 1--Cerebrospinal Fluid Shunt System Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Pyrogenicity/adverse tissue reaction...  Biocompatibility testing,
                                          Pyrogenicity testing,
                                          Labeling, Shelf-life testing,
                                          and Sterility testing.
Infection (including meningitis).......  Labeling, Sterility testing,
                                          and Package integrity testing.
Cerebrospinal fluid (CSF) leakage......  Labeling, and Non-clinical
                                          performance testing.
Over- and under-drainage                 Labeling, and Non-clinical
                                          performance testing.

[[Page 73975]]

 
     Spinal headache with and
     without CSF leakage.
     Intracranial hemorrhage...
     Hematoma (e.g., spinal,
     subdural).
     Paraplegia................
     Foreign body obstruction..
Procedural/use errors..................  Labeling.
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    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 510(k) 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 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) 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 25.34(b) 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.

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. 3501-3521). 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 0910-0844; the collections of 
information in 21 CFR part 820, regarding quality system regulation, 
have been approved under OMB control number 0910-0073; the collections 
of information in 21 CFR part 814, subparts A through E, regarding 
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding 
premarket notification submissions, have been approved under OMB 
control number 0910-0120; and the collections of information in 21 CFR 
part 801, regarding labeling, have been approved under OMB control 
number 0910-0485.

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 882--NEUROLOGICAL DEVICES

0
1. The authority citation for part 882 continues to read as follows:

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

0
2. Add Sec.  882.5560 to subpart F to read as follows:

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.

    Dated: December 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28157 Filed 12-28-21; 8:45 am]
BILLING CODE 4164-01-P