Rule2023-24717
Medical Devices; Hematology and Pathology Devices; Classification of the Container System for the Processing and Storage of Red Blood Cell Components Under Reduced Oxygen Conditions
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 9, 2023
Effective
November 9, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions 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 classification of the container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions. 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 88 Issue 216 (Thursday, November 9, 2023)</title>
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[Federal Register Volume 88, Number 216 (Thursday, November 9, 2023)]
[Rules and Regulations]
[Pages 77198-77200]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-24717]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 864
[Docket No. FDA-2023-N-4487]
Medical Devices; Hematology and Pathology Devices; Classification
of the Container System for the Processing and Storage of Red Blood
Cell Components Under Reduced Oxygen Conditions
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the container system for the processing and storage of Red
Blood Cell components under reduced oxygen conditions 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 classification of the container system for the processing and
storage of Red Blood Cell components under reduced oxygen conditions.
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 November 9, 2023. The classification was
applicable on September 15, 2023.
FOR FURTHER INFORMATION CONTACT: Karen Fikes, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the container system for the
processing and storage of Red Blood Cell components under reduced
oxygen conditions 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 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 January 5, 2022, FDA received Hemanext, Inc.'s request for De
Novo classification of the Hemanext One. 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,
[[Page 77199]]
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 September 15, 2023, 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
864.9115.\1\ We have named the generic type of device container system
for the processing and storage of Red Blood Cell components under
reduced oxygen conditions, identified as a device intended for medical
purposes that is used to process and store Red Blood Cell components
and reduce oxygen levels in the storage environment.
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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--Container System for the Processing and Storage of Red Blood
Cell Components Under Reduced Oxygen Conditions Risks to Health and
Mitigation Measures
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Identified risks to health Mitigation measures
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Toxicity that can result from contact of Biocompatibility
the component materials of the device with evaluation.
the red blood cells or patient's body.
Toxicity of leached materials, or residual Extractables and leachables
chemical sterilant, when in contact with testing.
red blood cells or transfused to patient.
Infection.................................. Sterilization validation;
Endotoxin testing; and
Container closure
evaluation.
Transfusion of poor quality red blood cells Nonclinical and clinical
because of inadequate storage conditions studies; Shelf-life
or device malfunction. testing; and Performance
testing.
Blood exposure because of device Performance testing.
malfunction.
Transfusion of poor quality red blood cells Labeling.
due to processing of Red Blood Cells
components collected from donors with
hemoglobin S.
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FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act. At the time of
classification, container system for the processing and storage of Red
Blood Cell components under reduced oxygen conditions is for
prescription use only. Prescription devices are exempt from the
requirement for adequate directions for use for the layperson under
section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR
801.5, as long as the conditions of 21 CFR 801.109 are met.
III. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in 21 CFR 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 864
Blood, Medical devices, Packaging and containers.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
864 is amended as follows:
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES
0
1. The authority citation for part 864 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 864.9115 to subpart J to read as follows:
Sec. 864.9115 Container system for the processing and storage of Red
Blood Cell components under reduced oxygen conditions.
(a) Identification. A container system for the processing and
storage of Red Blood Cell components under reduced oxygen conditions is
a device intended for medical purposes that is used to process and
store Red Blood Cell components and reduce oxygen levels in the storage
environment.
(b) Classification. Class II (special controls). The special
controls for this device are:
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(1) The intended use of the device must specify:
(i) The Red Blood Cell components that can be processed and stored
including acceptable anticoagulants and additive solutions;
(ii) The hold time after Red Blood Cell component collection;
(iii) The processing capacity (volume) of the device; and
(iv) The storage temperature and dating period of processed Red
Blood Cell components.
(2) Studies must demonstrate that the device is biocompatible and
include detailed documentation of the biocompatibility evaluation.
(3) Performance testing and nonclinical studies must include a
detailed study of leached materials extracted under conditions similar
to clinical usage of the device, and a toxicologic risk assessment of
those extracted or leached materials.
(4) Performance testing must support sterility of the device and
include sterilization validation, endotoxin testing, and container
closure integrity evaluation.
(5) Nonclinical and clinical studies must include evaluation of red
blood cell quality throughout the duration of storage based on in vitro
and in vivo studies, including hemolysis and red blood cell survival
and recovery.
(6) Performance studies must include:
(i) Detailed documentation of functional and mechanical testing,
including evaluation of oxygen and, if applicable, carbon dioxide
levels during Red Blood Cell components storage; and
(ii) Detailed documentation of device shelf-life testing
demonstrating continued sterility, package integrity, and functionality
over the identified shelf life.
(7) The labeling must include a contraindication against processing
Red Blood Cell components collected from donors with hemoglobin S.
Dated: November 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24717 Filed 11-8-23; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on November 9, 2023.
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