Rule2024-20081
Medical Devices; Gastroenterology-Urology Devices; Classification of the Hemodialyzer With Expanded Solute Removal Profile
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Published
September 6, 2024
Effective
September 6, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is classifying the hemodialyzer with expanded solute removal profile 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 hemodialyzer with expanded solute removal profile'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 89 Issue 173 (Friday, September 6, 2024)</title>
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[Federal Register Volume 89, Number 173 (Friday, September 6, 2024)]
[Rules and Regulations]
[Pages 72715-72717]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-20081]
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Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
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Federal Register / Vol. 89, No. 173 / Friday, September 6, 2024 /
Rules and Regulations
[[Page 72715]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA-2024-N-3972]
Medical Devices; Gastroenterology-Urology Devices; Classification
of the Hemodialyzer With Expanded Solute Removal Profile
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 hemodialyzer with expanded solute removal profile 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 hemodialyzer with expanded solute removal profile'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 September 6, 2024. The classification
was applicable on August 28, 2020.
FOR FURTHER INFORMATION CONTACT: Jade Noble, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2684, Silver Spring, MD 20993-0002, 240-402-5077,
<a href="/cdn-cgi/l/email-protection#fcb69d9899d2b2939e9099bc9a989dd294948fd29b938a"><span class="__cf_email__" data-cfemail="80cae1e4e5aeceefe2ece5c0e6e4e1aee8e8f3aee7eff6">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the hemodialyzer with expanded
solute removal profile as class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness.
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 (see also part 860, subpart D (21 CFR part 860, subpart D)).
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
510(k) process, when necessary, to market their device.
II. De Novo Classification
On September 16, 2019, FDA received Baxter Healthcare Corporation's
request for De Novo classification of the Theranova Dialyzers
(Theranova 400, Theranova 500). 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 August 28, 2020, FDA issued an order to the requester
[[Page 72716]]
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
876.5862.\1\ We have named the generic type of device hemodialyzer with
expanded solute removal profile, and it is identified as a device
intended for use as part of an artificial kidney system for the
treatment of patient with renal failure by performing such therapies as
hemodialysis, hemofiltration, and hemodiafiltration. A hemodialyzer
with expanded solute removal profile includes modifications to the
semipermeable membrane that allows for increased removal or uremic
retention solutes compared with standard high-flux hemodialyzers of the
high permeability hemodialysis system classification (Sec. 876.5860
(21 CFR 876.5860)) including solutes at the upper end of the ``middle''
molecular weight range (0.5 kDa to 60 kDa). This device is intended to
be used with the extracorporeal hemodialysis delivery systems, blood
tubing sets, blood access devices, and accessories regulated under 21
CFR 876.5820, 876.5860, 876.5540, and/or 876.5600.
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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--Hemodialyzer With Expanded Solute Removal Profile Risks and
Mitigation Measures
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Identified risks to health Mitigation measures
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Adverse tissue reaction........... Biocompatibility evaluation,
Pyrogenicity testing, and Non-
clinical performance testing.
Infection or pyrogen reaction..... Labeling, Pyrogenicity testing,
Sterilization validation, Non-
clinical performance testing, and
Shelf-life testing.
Inadequate or incomplete treatment Non-clinical performance testing,
Labeling, and Shelf-life testing.
Clearance of essential blood Non-clinical performance testing,
substances or medications. Clinical performance testing,
Labeling, and Shelf-life testing.
Blood loss or blood cell Non-clinical performance testing,
destruction. Labeling, and Shelf-life testing.
Blood leak into the dialysis fluid Non-clinical performance testing,
Labeling, and Shelf-life testing.
Air or particle embolism.......... Non-clinical performance testing,
Labeling, and Shelf-life testing.
Fluid imbalance................... Non-clinical performance testing and
Labeling.
Acid-base imbalance............... 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. 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 part 860, subpart D, regarding De Novo classification
have been approved under OMB control number 0910-0844; 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; 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
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.
List of Subjects in 21 CFR Part 876
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
876 is amended as follows:
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
0
1. The authority citation for part 876 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 876.5862 to read as follows:
Sec. 876.5862 Hemodialyzer with expanded solute removal profile.
(a) Identification. A hemodialyzer with expanded solute removal
profile is a device intended for use a part of an artificial kidney
system for the treatment of patients with renal failure by performing
such therapies as hemodialysis, hemofiltration, and hemodiafiltration.
A hemodialyzer with expanded solute removal profile includes
modifications to the semipermeable membrane that allows for increased
removal of uremic retention solutes compared with standard high-flux
hemodialyzers of the high permeability hemodialysis system
classification (Sec. 876.5860), including solutes at the upper end of
the ``middle'' molecular weight range (0.5 kDa to 60 kDa). This device
is intended to be used with the extracorporeal hemodialysis delivery
systems, blood tubing sets, blood access devices, and accessories
regulated under Sec. Sec. 876.5820, 876.5860, 876.5540, and/or
876.5600.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical performance testing under anticipated conditions of
use must
[[Page 72717]]
evaluate the solute removal profile and document all adverse events.
(2) Non-clinical performance testing data must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
(i) Ultrafiltration;
(ii) Blood and dialysate pressure drop;
(iii) Clearance rates;
(iv) Sieving coefficients;
(v) Mechanical hemolysis;
(vi) Structural integrity;
(vii) Blood compartment integrity;
(viii) Volume of the blood compartment; and
(ix) Endotoxin retention of the dialyzer membrane.
(3) The tissue-contacting components of the device must be
demonstrated to be biocompatible. Biocompatibility evaluation must
include a chemical analysis of the dialyzer membrane.
(4) Performance data must demonstrate the sterility of the patient-
contacting components of the device.
(5) The patient-contacting components of the device must be
demonstrated to be non-pyrogenic.
(6) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the identified shelf life.
(7) Device labeling must include:
(i) Shelf life;
(ii) Storage conditions;
(iii) Instructions for the preparation of the hemodialyzer,
initiation of dialysis, troubleshooting, and discontinuance of
dialysis;
(iv) Membrane surface area, priming (blood) volume, maximum
transmembrane pressure, maximum blood flow and maximum dialysate rate
for each model;
(v) A non-pyrogenic statement;
(vi) A summary of the in vitro performance data, provided in
tabular form; and
(vii) A summary of the clinical performance data.
Dated: August 30, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20081 Filed 9-5-24; 8:45 am]
BILLING CODE 4164-01-P
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