Rule2024-20999
Medical Devices; Therapeutic Devices; Classification of the Pediatric Continuous Renal Replacement Therapy System
Primary source
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Published
September 16, 2024
Effective
September 16, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the pediatric continuous renal replacement therapy 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 pediatric continuous renal replacement therapy 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 89 Issue 179 (Monday, September 16, 2024)</title>
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[Federal Register Volume 89, Number 179 (Monday, September 16, 2024)]
[Rules and Regulations]
[Pages 75493-75497]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-20999]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA-2024-N-4082]
Medical Devices; Therapeutic Devices; Classification of the
Pediatric Continuous Renal Replacement Therapy System
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
[[Page 75494]]
classifying the pediatric continuous renal replacement therapy 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 pediatric continuous renal replacement
therapy 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 September 16, 2024. The classification
was applicable on April 29, 2020.
FOR FURTHER INFORMATION CONTACT: Gema Gonzalez, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2530, Silver Spring, MD 20993-0002, 301-796-6519,
<a href="/cdn-cgi/l/email-protection#c384a6aea2ed84acadb9a2afa6b983a5a7a2edababb0eda4acb5"><span class="__cf_email__" data-cfemail="094e6c6468274e66677368656c73496f6d682761617a276e667f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the pediatric continuous renal
replacement therapy system 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 October 9, 2018, FDA received Medtronic, Inc.'s request for De
Novo classification of the CARPEDIEM 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 April 29, 2020, 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
876.5861.\1\ We have named the generic type of device pediatric
continuous renal replacement therapy system, and it is identified as a
device intended for use as an artificial kidney system for the
management of pediatric patients with acute kidney injury and/or fluid
overload by performing such therapies as hemodialysis, hemofiltration,
hemodiafiltration, and isolated ultrafiltration. Using a hemodialyzer
with a semipermeable membrane, the hemodialysis system removes toxins
or excess fluid from the patient's blood using the principles of
convection (via ultrafiltration) and/or diffusion (via a concentration
gradient in dialysate). The hemodialysis delivery machine, with an
automated ultrafiltration controller, controls and monitors the
parameters related to this processing, including the rate at which
blood and dialysate are pumped through the system, and the rate at
which fluid is removed from the patient. During treatment, a patient's
blood is circulated through the blood tubing set connected to the
hemodialyzer's blood compartment. Blood access devices and accessories
for hemodialysis required for the prescribed treatment are regulated
under 21 CFR 876.5540.
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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
[[Page 75495]]
required to mitigate these risks in table 1.
Table 1--Pediatric Continuous Renal Replacement Therapy System 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.
Death.................................. Labeling,
Clinical performance testing,
and
Usability testing.
Infection.............................. Labeling,
Reprocessing validation,
Pyrogenicity testing,
Shelf life testing, and
Usability testing.
Inadequate or incomplete treatment..... Non-clinical performance
testing;
Clinical performance testing;
Labeling;
Shelf-life testing;
Usability testing; and
Software verification,
validation, and hazard
analysis.
Clearance of essential blood substances Non-clinical performance
or medications. testing;
Clinical performance testing;
Labeling;
Shelf-life testing;
Usability testing; and
Software verification,
validation, and hazard
analysis.
Blood loss or blood cell destruction... Non-clinical performance
testing;
Clinical performance testing;
Labeling;
Shelf-life testing; and
Software verification,
validation, and hazard
analysis.
Thermal injury......................... Non-clinical performance
testing;
Clinical performance testing;
Labeling;
Shelf-life testing;
Usability testing; and
Software verification,
validation, and hazard
analysis.
Blood leak into the dialysis fluid..... Non-clinical performance
testing;
Clinical performance testing;
Labeling;
Shelf-life testing; and
Software verification,
validation, and hazard
analysis.
Fluid imbalance........................ Non-clinical performance
testing;
Clinical performance testing;
Labeling;
Shelf-life testing; and
Software verification,
validation, and hazard
analysis.
Air embolism........................... Non-clinical performance
testing;
Clinical performance testing;
Labeling;
Shelf-life testing;
Usability testing; and
Software verification,
validation, and hazard
analysis.
Fluid pump(s) reversal resulting in air Non-clinical performance
infusion via the arterial bloodline. testing;
Clinical performance testing;
Labeling;
Shelf-life testing;
Usability testing; and
Software, verification,
validation, and hazard
analysis.
Electrical shock....................... Electrical safety testing.
Electromagnetic interference with other Electromagnetic compatibility
devices/equipment. (EMC) testing.
------------------------------------------------------------------------
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,
[[Page 75496]]
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 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 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. 876.5861 to subpart F to read as follows:
Sec. 876.5861 Pediatric continuous renal replacement therapy system.
(a) Identification. A pediatric continuous renal replacement
therapy hemodialysis system is a device intended for use as an
artificial kidney system for the management of pediatric patients with
acute kidney injury and/or fluid overload by performing such therapies
as hemodialysis, hemofiltration, hemodiafiltration, and isolated
ultrafiltration. Using a hemodialyzer with a semipermeable membrane,
the hemodialysis system removes toxins or excess fluid from the
patient's blood using the principles of convection (via
ultrafiltration) and/or diffusion (via a concentration gradient in
dialysate). The hemodialysis delivery machine, with an automated
ultrafiltration controller, controls and monitors the parameters
related to this processing, including the rate at which blood and
dialysate are pumped through the system, and the rate at which fluid is
removed from the patient. During treatment, a patient's blood is
circulated through the blood tubing set connected to the hemodialyzer's
blood compartment. Blood access devices and accessories for
hemodialysis required for the prescribed treatment are regulated under
Sec. 876.5540.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical performance testing must confirm the safety and the
accuracy, precision, and reproducibility of the non-clinical
performance data under anticipated conditions of use.
(2) Usability testing must demonstrate that a user can correctly
use the hemodialysis delivery device based solely on reading the
instructions for use.
(3) 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) Hemodialysis delivery system performance testing must include:
(A) Fluid flow accuracy testing; and
(B) Functional testing of system components including sensors,
pumps, and scales to acceptance criteria.
(ii) Hemodialyzer performance testing must include:
(A) Ultrafiltration;
(B) Blood and dialysate pressure drop;
(C) Clearance rates;
(D) Sieving coefficients;
(E) Mechanical hemolysis;
(F) Structural integrity;
(G) Blood compartment integrity;
(H) Volume of the blood compartment; and
(I) Chemical analysis of the dialyzer membrane.
(iii) Blood tubing set performance testing must include:
(A) Pressure leak testing;
(B) Worst-case endurance testing;
(C) Priming volume assessment;
(D) Tensile testing of joints and materials of all tubing segments;
(E) Pressure transducer leak testing;
(F) Clamp occlusion;
(G) Mechanical hemolysis; and
(H) Kink testing.
(4) Software verification, validation, and hazard analysis must be
performed.
(5) Performance data must demonstrate the electromagnetic
compatibility (EMC), electrical safety, and wireless compatibility of
the device.
(6) The tissue-contacting components of the device must be
demonstrated to be biocompatible.
(7) Performance data must demonstrate the sterility of the patient-
contacting components of the device.
(8) Performance data must validate the reprocessing instructions
for the reusable components of the device.
(9) The patient-contacting components of the device must be
demonstrated to be non-pyrogenic.
(10) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the identified shelf life.
(11) Device labeling must include:
(i) Hemodialysis delivery system labeling must provide detailed
information regarding the safe use of the dialysis machine, including:
(A) Overall description of the device and individual components or
accessories labeled for use with the delivery system;
(B) Description of the safety-related components included in the
system;
(C) Identification of operational parameters;
(D) Alarms and troubleshooting information;
(E) Cleaning, disinfection, and preventative maintenance
procedures; and
(F) A statement that the device is intended for use by operators
trained in the administration of continuous renal replacement therapy
and in the management of its complications.
(ii) Hemodialyzer labeling must include:
(A) Description of compatibility;
(B) Shelf life;
(C) Storage conditions;
(D) Instructions for the preparation of the hemodialyzer,
initiation of dialysis, troubleshooting, and discontinuance of
dialysis;
(E) Membrane surface area, priming (blood) volume, maximum
transmembrane pressure, maximum blood flow and maximum dialysate rate
for each model;
(F) Summary of the in vitro performance data; and
(G) A non-pyrogenic statement.
(iii) Blood tubing set labeling must provide detailed information
regarding the safe use of the device, including:
(A) Description of compatibility;
(B) Shelf life;
(C) Storage conditions;
(D) Identification of the components in the package;
[[Page 75497]]
(E) Total length of the arterial and venous tubing sets;
(F) Outer diameter (OD) of the pump segment;
(G) Priming volume;
(H) Identification of the hemodialysis delivery systems which are
compatible with the blood tubing set;
(I) Identification of the largest gauge needle that can be used
with the injection port, if applicable; and
(J) Identification of the maximum operating pressures for the
transducer protectors.
Dated: September 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20999 Filed 9-13-24; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on September 16, 2024.
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