Medical Devices; Therapeutic Devices; Classification of the Pediatric Continuous Renal Replacement Therapy System, 75493-75497 [2024-20999]
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Federal Register / Vol. 89, No. 179 / Monday, September 16, 2024 / Rules and Regulations
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
parts 801 and 809, regarding labeling,
have been approved under OMB control
number 0910–0485.
List of Subjects in 21 CFR Part 866
Biologics, Laboratories, 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 866 is
amended as follows:
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PART 866—IMMUNOLOGY AND
MICROBIOLOGY DEVICES
1. The authority citation for part 866
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 866.3236 to subpart D to read
as follows:
■
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§ 866.3236 Device to detect or measure
nucleic acid from viruses associated with
head and neck cancers.
(a) Identification. A device to detect
or measure nucleic acid from viruses
associated with head and neck cancers
is an in vitro diagnostic test for
prescription use in the detection of viral
nucleic acid in nasopharyngeal or
oropharyngeal cellular specimens from
patients with signs and symptoms of
head and neck cancer. The test result is
intended to be used in conjunction with
other clinical information to aid in
assessing the clinical status of virusassociated head and neck cancers and/
or the likelihood that head and neck
cancer is present.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Any device used for specimen
collection and transport must be FDAcleared, -approved, or -classified as
510(k) exempt (standalone or as part of
a test system) for the collection of
human specimens; alternatively, the
sample collection device must be
cleared in a premarket submission as a
part of this device.
(2) The labeling required under
§ 809.10(b) of this chapter must include,
as determined to be appropriate by FDA:
(i) An intended use statement that
includes the following:
(A) The analyte(s) detected by the
device;
(B) Data output of the device
(qualitative, semiquantitative, or
quantitative);
(C) The specimen types with which
the device is intended for use;
(D) The clinical indications
appropriate for test use (e.g., in
conjunction with endoscopy);
(E) The intended use populations
(e.g., signs and symptoms, ethnicity);
and
(F) The intended use location(s) (e.g.,
specific name and location of testing
facility or facilities).
(ii) A detailed device description,
including reagents, instruments,
ancillary materials, specimen collection
and transport devices, controls, and a
detailed explanation of the
methodology, including all preanalytical methods for processing of
specimens.
(iii) A detailed explanation of the
interpretation of results.
(iv) Limiting statements indicating:
(A) The device is not intended for use
in screening for head and neck cancer
in asymptomatic populations.
(B) Results of the device are not
predictive of a patient’s future risk of
head and neck cancer.
(C) Patients who test negative for the
virus should be managed in accordance
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75493
with the standard of care, based on the
assessment of endoscopy and/or other
clinical information by a licensed
healthcare professional.
(D) Results of the device are not
intended to be used as the sole basis for
determining the need for biopsy or for
any other patient management decision.
(3) Design verification and validation
must include the following:
(i) A detailed device description
including pre-analytical specimen
processing, assay technology, target
region, primer/probe sequences,
reagents, controls, instrument
requirements, and the computational
path from collected raw data to reported
result.
(ii) Detailed documentation and
results from analytical performance
studies, including characterization of
the cutoff(s), limit of detection, limit of
quantitation, precision (including
multisite reproducibility, if applicable),
inclusivity, cross-reactivity,
interference, carryover/crosscontamination, reagent stability, and
specimen/sample stability, as
determined to be appropriate by FDA.
(iii) Detailed documentation of a
clinical performance study that includes
patients from the intended use
population, including the clinical study
protocol, with a predefined statistical
analysis plan, and a clinical study
report with testing results and results of
all statistical analyses.
(iv) A detailed description of the
impact of any software, including
software applications and software
incorporated in hardware-based devices,
on the device’s functions.
Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–20896 Filed 9–13–24; 8:45 am]
BILLING CODE 4164–01–P
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.
The Food and Drug
Administration (FDA, Agency, or we) is
SUMMARY:
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Federal Register / Vol. 89, No. 179 / Monday, September 16, 2024 / Rules and Regulations
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,
Gema.Gonzalez@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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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).
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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
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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.
FDA has identified the following risks
to health associated specifically with
this type of device and the measures
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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75495
required to mitigate these risks in table
1.
TABLE 1—PEDIATRIC CONTINUOUS RENAL REPLACEMENT THERAPY SYSTEM RISKS AND MITIGATION MEASURES
Identified risks to health
Mitigation measures
Adverse tissue reaction ..........................................................................................
Death ......................................................................................................................
Infection ..................................................................................................................
Inadequate or incomplete treatment ......................................................................
Clearance of essential blood substances or medications .....................................
Blood loss or blood cell destruction .......................................................................
Thermal injury ........................................................................................................
Blood leak into the dialysis fluid ............................................................................
Fluid imbalance ......................................................................................................
Air embolism ..........................................................................................................
Fluid pump(s) reversal resulting in air infusion via the arterial bloodline ..............
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Electrical shock ......................................................................................................
Electromagnetic interference with other devices/equipment .................................
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
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Biocompatibility evaluation,
Pyrogenicity testing, and
Non-clinical performance testing.
Labeling,
Clinical performance testing, and
Usability testing.
Labeling,
Reprocessing validation,
Pyrogenicity testing,
Shelf life testing, and
Usability testing.
Non-clinical performance testing;
Clinical performance testing;
Labeling;
Shelf-life testing;
Usability testing; and
Software verification, validation, and hazard analysis.
Non-clinical performance testing;
Clinical performance testing;
Labeling;
Shelf-life testing;
Usability testing; and
Software verification, validation, and hazard analysis.
Non-clinical performance testing;
Clinical performance testing;
Labeling;
Shelf-life testing; and
Software verification, validation, and hazard analysis.
Non-clinical performance testing;
Clinical performance testing;
Labeling;
Shelf-life testing;
Usability testing; and
Software verification, validation, and hazard analysis.
Non-clinical performance testing;
Clinical performance testing;
Labeling;
Shelf-life testing; and
Software verification, validation, and hazard analysis.
Non-clinical performance testing;
Clinical performance testing;
Labeling;
Shelf-life testing; and
Software verification, validation, and hazard analysis.
Non-clinical performance testing;
Clinical performance testing;
Labeling;
Shelf-life testing;
Usability testing; and
Software verification, validation, and hazard analysis.
Non-clinical performance testing;
Clinical performance testing;
Labeling;
Shelf-life testing;
Usability testing; and
Software, verification, validation, and hazard analysis.
Electrical safety testing.
Electromagnetic compatibility (EMC) testing.
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.
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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,
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Federal Register / Vol. 89, No. 179 / Monday, September 16, 2024 / Rules and Regulations
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—GASTROENTEROLOGYUROLOGY DEVICES
1. The authority citation for part 876
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 876.5861 to subpart F to read
as follows:
■
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§ 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
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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 § 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.
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(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 patientcontacting 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;
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(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
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Part 214
[Docket No. FR–6388–F–02]
RIN 2502–AJ70
Modernizing the Delivery of Housing
Counseling Services
Office of the Assistant
Secretary for Housing—Federal Housing
Commissioner, HUD.
ACTION: Final rule.
AGENCY:
The Department of Housing
and Urban Development (HUD) is
issuing this final rule to update HUD’s
regulations that require participating
agencies to provide in-person
counseling to clients that prefer this
format to reflect advances in technology,
align with client engagement
preferences, and preserve consumer
protections. The final rule amends
HUD’s regulations to allow housing
counseling agencies to use alternative
communication methods, including
virtual meeting tools, in lieu of
providing in-person services.
Participating agencies that choose not to
provide in-person services are required
to refer clients to local providers that
provide such services, when requested.
After considering public comments
received in response to the proposed
rule HUD published on October 25,
2023, this final rule adopts the proposed
rule without change.
DATES: Effective October 16, 2024.
FOR FURTHER INFORMATION CONTACT:
David Valdez, Senior Housing Program
Specialist, Department of Housing and
Urban Development, 1331 Lamar St.
Suite 550, Houston, TX 77002,
telephone 713–718–3178 (this is not a
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SUMMARY:
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toll-free number). HUD welcomes and is
prepared to receive calls from
individuals who are deaf or hard of
hearing, as well as individuals with
speech or communication disabilities.
To learn more about how to make an
accessible telephone call, please visit
https://www.fcc.gov/consumers/guides/
telecommunications-relay-service-trs.
SUPPLEMENTARY INFORMATION:
I. Background
Section 106 of the Housing and Urban
Development Act of 1968 (12 U.S.C.
1701x) (Section 106) authorizes HUD’s
Housing Counseling program (see
Sections 106(a)(1)(iii) and 106(a)(2)). On
October 25, 2023, HUD published the
‘‘Modernizing the Delivery of Housing
Counseling Services’’ proposed rule
(‘‘the proposed rule’’) in the Federal
Register, at 88 FR 73298, to revise the
current regulations governing HUD’s
Housing Counseling program to align
with client engagement preferences, and
to preserve consumer protections, while
leaving in place existing guardrails that
ensure participating agencies
demonstrate knowledge and a
connection to the community they
serve, whether they choose to do so by
providing virtual, in-person, or hybrid
services.
As described in the proposed rule, on
September 28, 2007, HUD published a
final rule titled, ‘‘Housing Counseling
Program,’’ at 72 FR 55637, which
established regulations for HUD’s
Housing Counseling program (see 24
CFR 214.103(l) and 24 CFR 214.300, in
particular). These regulations had not
been amended since they were
established. Section 214.300(a)(3)
required agencies that provide housing
counseling services to provide in-person
counseling services at one of the
agency’s facilities or an alternate
location to clients that preferred that
format. When this requirement was
adopted, housing counseling and
education were primarily conducted inperson and the conventional wisdom
was that in-person service was the most
effective service delivery method.
However, alternatives to in-person
service have also proven to be effective.
In 2020, due to ongoing public health
concerns around the spread of
Coronavirus Disease 2019 (COVID–19),
HUD issued a Temporary Partial Waiver
of 24 CFR 214.300(a)(3), In-Person
Housing Counseling Requirement, that
allowed housing counseling agencies to
utilize alternative methods to conduct
housing counseling and education with
clients in lieu of meeting in-person.
Feedback received regarding this waiver
indicated that these alternative methods
were more practical, cost-effective, and
PO 00000
Frm 00053
Fmt 4700
Sfmt 4700
75497
accessible, and did not lead to adverse
compliance issues or negative financial
impacts. This feedback, increased
consumer preference for virtual service
delivery, and reduced burdens and costs
for participating agencies, all weigh in
favor of modernizing the current
regulations.
HUD’s proposed rule, then, proposed
amending the regulations such that
participating agencies must maintain at
least one facility and may provide
remote housing counseling. Additional
details about the proposed rule may be
found at 88 FR 73298 (October 25,
2023).
II. Final Rule
This final rule adopts the proposed
rule without change. This rule will help
reduce the costs of providing housing
counseling by allowing participating
agencies to provide housing counseling
services at a facility or at an alternate
location, via telephone, or via
collaborative online software. All
facilities must have an identified,
private space available for the provision
of counseling services, whether those
services are in-person or virtual, and
housing counseling agencies that do not
provide in-person counseling services
must refer clients to agencies that
provide in-person counseling services
upon a client’s request. This rule does
not change the requirements that every
housing counseling agency must
continue to meet for HUD approval as
a counseling agency, regardless of the
setting or format of housing counseling
services, including having functioned
for at least one year in the geographical
area(s) the agency identified in its
housing counseling work plan, having
sufficient resources to implement that
proposed work plan, and being able to
demonstrate knowledge of local housing
markets and community resources.
III. The Public Comments
HUD received 33 public comments on
the proposed rule from various
interested parties, including housing
finance companies, housing counseling
service agencies (including HUDapproved agencies), housing counselors,
state housing agency associations,
community development and other
nonprofit organizations, and other
individuals and entities.
Support for the Rule
Most commenters supported HUD’s
proposal and supported providing
individuals with options for different
formats and types of housing counseling
services, including telephonic and
online services. Some commenters cited
general benefits such as increased
E:\FR\FM\16SER1.SGM
16SER1
]]>Agencies
[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 [www.gpo.gov]
[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,
[email protected].
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
------------------------------------------------------------------------
Identified risks to health Mitigation measures
------------------------------------------------------------------------
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
