Rule2024-20254
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Blood Collection Device for Cell-Free Nucleic Acids
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
September 9, 2024
Effective
September 9, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the blood collection device for cell-free nucleic acids 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 blood collection device for cell-free nucleic acids' 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, in part by reducing regulatory burdens.
Full Text
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<title>Federal Register, Volume 89 Issue 174 (Monday, September 9, 2024)</title>
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[Federal Register Volume 89, Number 174 (Monday, September 9, 2024)]
[Rules and Regulations]
[Pages 72982-72984]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-20254]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
[Docket No. FDA-2024-N-4086]
Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of the Blood Collection Device for Cell-Free
Nucleic Acids
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the blood collection device for cell-free nucleic acids
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 blood collection device for cell-free nucleic
acids' 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, in part by reducing regulatory burdens.
DATES: This order is effective September 9, 2024. The classification
was applicable on August 7, 2020.
FOR FURTHER INFORMATION CONTACT: Lindsey Coe, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3556, Silver Spring, MD 20993-0002, 240-402-5267,
<a href="/cdn-cgi/l/email-protection#84c8edeae0f7e1fdaac7ebe1c4e2e0e5aaececf7aae3ebf2"><span class="__cf_email__" data-cfemail="672b0e090314021e4924080227010306490f0f1449000811">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the blood collection device for
cell-free nucleic acids 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
[[Page 72983]]
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 (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 10, 2020, FDA received Streck, Inc.'s request for De
Novo classification of the Cell-Free DNA BCT. 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 7, 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
862.1676.\1\ We have named the generic type of device blood collection
device for cell-free nucleic acids, and it is identified as intended
for medical purposes to collect, store, transport, and handle blood
specimens and to stabilize and isolate cell-free nucleic acid
components prior to further testing.
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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--Blood Collection Device for Cell-Free Nucleic Acids Risks and
Mitigation Measures
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Identified risks to health Mitigation measures
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Blood pathogen exposure/Injury............ Certain design verification
and validation.
Failure to collect and transport sample... Certain design verification
and validation.
Insufficient sample quantity and quality.. Certain design verification
and validation.
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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
parts 801 and 809, regarding labeling, have been approved under OMB
control number 0910-0485.
List of Subjects in 21 CFR Part 862
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
862 is amended as follows:
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
0
1. The authority citation for part 862 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 862.1676 to subpart B to read as follows:
[[Page 72984]]
Sec. 862.1676 Blood collection device for cell-free nucleic acids.
(a) Identification. A blood collection device for cell-free nucleic
acids is a device intended for medical purposes to collect, store,
transport, and handle blood specimens and to stabilize and isolate
cell-free nucleic acid components prior to further testing.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Design verification and validation documentation must include
appropriate design inputs and design outputs that are essential for the
proper functioning of the device for its intended use, including all of
its indications for use, and must include the following:
(i) Documentation demonstrating that appropriate, as determined by
FDA, measures are in place (e.g., validated device design features and
specifications) to ensure that users of blood collection device for
cell-free nucleic acids devices are not exposed to undue risk of
bloodborne pathogen exposure and operator injury during use of the
device, including blood collection, transportation, and centrifugation
processes.
(ii) Documentation demonstrating that appropriate, as determined by
FDA, measures are in place (e.g., validated device design features and
specifications) to ensure that the device reproducibly and reliably
collects, transports, stabilizes, and isolates cell-free nucleic acids
of sufficient yield and quality suitable for downstream applications as
appropriate for its intended use. At a minimum, these measures must
include:
(A) Data demonstrating that blood samples collected in the device
have reproducible cell-free nucleic acid yields that are suitable, as
determined by FDA, for downstream testing as appropriate for the
intended use, including estimates of within-lot, within-device, and
lot-to-lot variability;
(B) Data demonstrating that cell-free nucleic acid yields isolated
from blood specimens collected into the device do not add clinically
significant bias to test results obtained using the downstream
application(s) described in the intended use. For devices indicated for
use with multiple downstream applications, data demonstrating
acceptable performance for each type of claimed use or, alternatively,
an appropriate, as determined by FDA, clinical justification for why
such data are not needed;
(C) Data demonstrating that the device appropriately stabilizes
cell-free nucleic acids after sample collection, during storage, and
during transport over the claimed shelf life of the device;
(D) Data demonstrating that samples collected in the device have
minimal levels of contamination with other types of nucleic acids
present in cells or cellular components, and that these levels of
contamination do not interfere with downstream testing;
(E) Data from analytical or clinical studies that demonstrate that,
when used as intended, the device consistently draws a blood sample
volume that is within the indicated fill range;
(F) Data from analytical or clinical studies that demonstrate that,
when used as intended, cell-free nucleic acid yield, stability, and
quality are not significantly impacted by interference due to other
parts of the device (such as reduced or excess active ingredient) or
specimen collection and processing procedures (such as hemolysis,
centrifugation, or mixing of blood with anticoagulant or additives);
and
(G) Data from analytical studies that demonstrate that the device
is suitable for its intended use across all storage and sample handling
conditions described in the device labeling, including device shelf
life and shipping conditions (e.g., temperature, humidity, duration).
(iii) A protocol, reviewed and determined acceptable by FDA, that
specifies the verification and validation activities that will be
performed for anticipated device modifications to reevaluate
performance claims or performance specifications. This protocol must
include a process for assessing whether a modification to technology,
engineering, performance, materials, specifications, or indications for
use, or any combination thereof, could significantly affect the safety
or effectiveness of the device. The protocol must include assessment
metrics, acceptance criteria, and analytical methods for the
performance testing of changes.
Dated: September 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20254 Filed 9-6-24; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on September 9, 2024.
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