Rule2022-28168
Medical Devices; Cardiovascular Devices; Classification of the Extracorporeal System for Carbon Dioxide Removal
Primary source
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Published
December 29, 2022
Effective
December 29, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the extracorporeal system for carbon dioxide removal 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 extracorporeal system for carbon dioxide removal'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 87 Issue 249 (Thursday, December 29, 2022)</title>
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[Federal Register Volume 87, Number 249 (Thursday, December 29, 2022)]
[Rules and Regulations]
[Pages 80038-80040]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-28168]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA-2022-N-3186]
Medical Devices; Cardiovascular Devices; Classification of the
Extracorporeal System for Carbon Dioxide Removal
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the extracorporeal system for carbon dioxide removal 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 extracorporeal system for carbon dioxide
removal'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, 2022. The classification
was applicable on November 13, 2021.
FOR FURTHER INFORMATION CONTACT: Alejandra Cambonchi, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 2253, Silver Spring, MD 20993-0002,
301-796-0552, <a href="/cdn-cgi/l/email-protection#1958757c7378777d6b78375a78747b76777a7170597f7d783771716a377e766f"><span class="__cf_email__" data-cfemail="6c2d0009060d02081e0d422f0d010e03020f04052c0a080d4204041f420b031a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the extracorporeal system for
carbon dioxide removal 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, in part by placing the
device into a lower device class than the automatic class III
assignment.
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 (see 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 device 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 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. 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.
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
On August 30, 2021, FDA received ALung Technologies, Inc.'s request
for De Novo classification of the Hemolung Respiratory Assist System.
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 21 U.S.C. 360c(a)(1)(B)). 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 November 13, 2021, 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
870.4150.\1\ We have named the generic type of device extracorporeal
system for carbon dioxide removal, and
[[Page 80039]]
it is identified as a system of devices and accessories that provides
assisted extracorporeal carbon dioxide removal from the patient's blood
in patients with acute respiratory failure, where other available
treatment options have failed, and continued clinical deterioration is
expected or the risk of death is imminent. The main devices and
accessories of the system include, but are not limited to, the console
(hardware), software, and disposables, including, but not limited to, a
gas exchanger, blood pump, cannulae, tubing, filters, and other
accessories (e.g., monitors, detectors, sensors, connectors).
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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--Extracorporeal System for Carbon Dioxide Removal Risks and
Mitigation Measures
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Identified risks Mitigation measures
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Bleeding, Thrombocytopenia, In Vivo Evaluation, Non-clinical
Hemolysis, Thrombosis. performance testing, and Labeling.
Infection.................... In Vivo Evaluation, Sterility, Shelf-life
testing, and Labeling.
Adverse Tissue and/or In Vivo Evaluation, Biocompatibility, and
Hematologic Reaction. Labeling.
Mechanical Failure........... In Vivo Evaluation, Non-clinical
performance testing, Labeling, and
Software Validation, verification, and
hazard analysis.
Hemodynamic Instability...... In Vivo Evaluation, Non-clinical
performance testing, and Labeling.
Hypothermia.................. In Vivo Evaluation, Non-clinical
performance testing, and Labeling.
Mechanical Injury to Access In Vivo Evaluation, Non-clinical
Vessels. performance testing, and Labeling.
Inadequate gas exchange...... In Vivo Evaluation, Non-clinical
performance testing, and Labeling.
Hemodilution................. In Vivo Evaluation, Non-clinical
performance testing, and Labeling.
Gas embolism................. In Vivo Evaluation, Non-clinical
performance testing, and 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. We encourage sponsors to consult with us if they wish to
use a non-animal testing method they believe is suitable, adequate,
validated, and feasible. We will consider if such an alternative method
could be assessed for equivalency to an animal test method. This device
is subject to premarket notification requirements under section 510(k)
of the FD&C Act.
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 21 CFR part 860, subpart D, regarding De Novo
classification have been approved under OMB control number 0910-0844;
the collections of information in 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; the collections of information in
21 CFR part 820, regarding quality system regulation, have been
approved under OMB control number 0910-0073; and the collections of
information in 21 CFR parts 801, regarding labeling, have been approved
under OMB control number 0910-0485.
List of Subjects in 21 CFR Part 870
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
870 is amended as follows:
PART 870--CARDIOVASCULAR DEVICES
0
1. The authority citation for part 870 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 870.4150 to subpart E to read as follows:
Sec. 870.4150 Extracorporeal system for carbon dioxide removal.
(a) Identification. An extracorporeal system for carbon dioxide
removal is a system of devices and accessories that provides assisted
extracorporeal carbon dioxide removal from the patient's blood in
patients with acute respiratory failure, where other available
treatment options have failed, and continued clinical deterioration is
expected or the risk of death is imminent. The main devices and
accessories of the system include, but are not limited to, the console
(hardware), software, and disposables, including, but not limited to, a
gas exchanger, blood pump, cannulae, tubing, filters, and other
accessories (e.g., monitors, detectors, sensors, connectors).
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) In vivo evaluation, which may include animal testing and
clinical data, of the devices and accessories in the circuit must
demonstrate their performance over the intended duration of use,
including a detailed summary of the in vivo evaluation pertinent to the
use of the devices and accessories to demonstrate their effectiveness.
(2) The technological characteristics of the device must ensure
that the geometry and design parameters are consistent with the
intended use, and that the devices and accessories in the circuit are
compatible.
(3) Non-clinical performance testing of the devices and accessories
in the circuit must demonstrate that the device performs as intended
under anticipated conditions of use. The following performance
characteristics must be tested:
(i) Mechanical integrity;
(ii) Durability; and
[[Page 80040]]
(iii) Reliability.
(4) All patient contacting components of the device must be
demonstrated to be biocompatible.
(5) Performance testing must demonstrate the electrical safety and
electromagnetic compatibility (EMC) of any electrical components.
(6) Software validation, verification, and hazard analysis must be
performed.
(7) Performance testing must demonstrate the sterility of all
patient-contacting components.
(8) Performance testing must support the shelf life of the device
by demonstrating continued sterility and device functionality over the
identified shelf life.
(9) Labeling must include the following:
(i) A detailed summary of the non-clinical and in vivo evaluations
pertinent to use of the device and accessories in the circuit;
(ii) Adequate instructions with respect to circuit setup,
performance characteristics with respect to compatibility among
different devices and accessories in the circuit, and maintenance
during a procedure; and
(iii) A shelf life.
Dated: December 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28168 Filed 12-28-22; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on December 29, 2022.
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