Rule2021-28157
Medical Devices; Neurological Devices; Classification of the Cerebrospinal Fluid Shunt System
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 29, 2021
Effective
December 29, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 247 (Wednesday, December 29, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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,
<a href="/cdn-cgi/l/email-protection#b3ebdad2dcdfdadd9de9dbd6ddd4f3d5d7d29ddbdbc09dd4dcc5"><span class="__cf_email__" data-cfemail="cf97a6aea0a3a6a1e195a7aaa1a88fa9abaee1a7a7bce1a8a0b9">[email protected]</span></a>.
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 DUET<SUP>TM</SUP> 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 DUET<SUP>TM</SUP> 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]]
<bullet> Spinal headache with and
without CSF leakage.
<bullet> Intracranial hemorrhage...
<bullet> Hematoma (e.g., spinal,
subdural).
<bullet> Paraplegia................
<bullet> 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
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