Rule2025-08151
Medical Devices; Hematology and Pathology Devices; Classification of the Coagulation System for the Measurement of Whole Blood Viscoelastic Properties in Perioperative Patients
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
May 9, 2025
Effective
May 9, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients 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 coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients' 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
<html>
<head>
<title>Federal Register, Volume 90 Issue 89 (Friday, May 9, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 89 (Friday, May 9, 2025)]
[Rules and Regulations]
[Pages 19629-19631]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08151]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 864
[Docket No. FDA-2025-N-0711]
Medical Devices; Hematology and Pathology Devices; Classification
of the Coagulation System for the Measurement of Whole Blood
Viscoelastic Properties in Perioperative Patients
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Final amendment; final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the coagulation system for the measurement of whole blood
viscoelastic properties in perioperative patients 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 coagulation system for the measurement of whole blood
viscoelastic properties in perioperative patients' 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 May 9, 2025. The classification was
applicable on March 12, 2019.
FOR FURTHER INFORMATION CONTACT: Dina Jerebitski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3574, Silver Spring, MD 20993-0002, 301-
796-2411, <a href="/cdn-cgi/l/email-protection#8fcbe6e1eea1c5eafdeaede6fbfce4e6cfe9ebeea1e7e7fca1e8e0f9"><span class="__cf_email__" data-cfemail="ebaf82858ac5a18e998e89829f988082ab8d8f8ac5838398c58c849d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the coagulation system for the
measurement of whole blood viscoelastic properties in perioperative
patients as class II (special controls), which we have determined will
provide a reasonable assurance of safety and effectiveness. In
addition, we believe this action will enhance patients' access to
beneficial innovation, in part by reducing regulatory burdens by
placing the device into a lower device class than the automatic class
III assignment.
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.
We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. 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) (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
less-burdensome 510(k) process, when necessary, to market their device.
II. De Novo Classification
On April 2, 2018, FDA received HemoSonics, LLC's, request for De
Novo classification of the Quantra QPlus 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 March 12, 2019, 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
[[Page 19630]]
CFR 864.5430.\1\ We have named the generic type of device ``coagulation
system for the measurement of whole blood viscoelastic properties in
perioperative patients,'' and it is identified as an in vitro
diagnostic device used to evaluate blood coagulation, fibrinolysis, or
both, in perioperative patients, as an aid in the assessment of
coagulopathies when used in conjunction with clinical signs and
symptoms and other clinical and laboratory findings.
---------------------------------------------------------------------------
\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 required to
mitigate these risks in table 1.
Table 1--Coagulation System for the Measurement of Whole Blood
Viscoelastic Properties in Perioperative Patients Risks and Mitigation
Measures
------------------------------------------------------------------------
Identified risks to health Mitigation measures
------------------------------------------------------------------------
Incorrect test results............... Transparent device performance
descriptions in labeling;
Transparent device limitations
descriptions in labeling; and
Certain precision, performance,
interference, and specimen
stability testing.
Incorrect interpretation of test Transparent device performance
results. descriptions in labeling;
Transparent device limitations
descriptions in labeling; and
Certain precision, performance,
interference, specimen
stability, and human factors
testing.
Cartridge malfunction................ Transparent device performance
descriptions in labeling;
Transparent device limitations
descriptions in labeling; and
Certain precision, performance,
interference, and specimen
stability 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, 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, subpart 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 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. 864.5430 to subpart F to read as follows:
Sec. 864.5430 Coagulation system for the measurement of whole blood
viscoelastic properties in perioperative patients.
(a) Identification. A coagulation system for the measurement of
whole blood viscoelastic properties in perioperative patients is an in
vitro diagnostic device used to evaluate blood coagulation,
fibrinolysis, or both, in perioperative patients, as an aid in the
assessment of coagulopathies when used in conjunction with clinical
signs and symptoms and other clinical and laboratory findings.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Design verification and validation must include detailed
documentation of, and results from, the following:
(i) A study assessing precision using protocols determined to be
acceptable by FDA, to cover the measurement range for each reported
parameter (test output). Testing must include native specimens with
coagulation profiles representative of the intended use population. In
order to cover the measuring range, testing may include a limited
number of contrived specimens, not to exceed 10 to 20 percent, or as
otherwise deemed appropriate by FDA. The contrived specimens must be
prepared to resemble clinical specimens. This testing must evaluate
repeatability and reproducibility and provide assessments of within-
run, within-day, between-run, between-day, between-reagent lot,
between-instrument, between-site, and between-
[[Page 19631]]
operator precision, as applicable to the system;
(ii) Studies that demonstrate the performance of each parameter
(test output) throughout the claimed measurement range, to include
linearity studies or dose-response studies, as applicable to the
parameter (test output);
(iii) Potential interferent study that includes evaluation of
hemolyzed and lipemic samples as potential interferents; exogenous and
endogenous interferents associated with each patient population
intended for use with the device, and which might be expected to affect
assay performance, must be evaluated; and potential interferents that
are specific for, or related to, the technology or methodology of the
device. Evaluation of all potential interferents must be performed
using a protocol determined to be acceptable to the FDA (e.g., an FDA-
recognized standard) and include both normal and abnormal specimens
covering coagulation profiles representative of the intended use
population;
(iv) A study that evaluates specimen stability under the intended
conditions for specimen collection, handling, and storage, using
samples that cover the coagulation profiles representative of the
intended use population, and using protocols determined to be
acceptable by FDA;
(v) A multisite clinical study, determined to be acceptable by FDA,
demonstrating performance, relative to clinically relevant and
clinically validated laboratory test(s) for each parameter (test
output). Further, the study must meet all of the following criteria:
(A) The study must be performed in the intended use population and
include representation from all patient populations for whom the device
is intended to be used. Potential endogenous and exogenous interferents
for each target patient population must be evaluated or known prior to
the study;
(B) The study must be conducted at a minimum of three external
sites representative of the intended use setting by the intended
operators;
(C) Test samples must be collected at time intervals relevant to
the device's use in the intended use population;
(D) Clinical specimens, which cover coagulation profiles
representative of the intended use population, must be evaluated at
each of the three clinical sites in the study;
(E) Analysis of the concordance of clinical interpretation of
patient coagulation status made from individual test parameter (test
output) results as compared to clinical interpretation of coagulation
status from a clinically relevant laboratory test or tests (e.g., a
comparative viscoelastic device or standard laboratory tests) must be
conducted; and
(F) Expected (reference) values for each parameter (test output)
must be demonstrated by testing a statistically appropriate number of
samples from apparently healthy normal individuals;
(vi) For a device with a user interface that has information that
needs to be interpreted by the user in correctly using the device to
achieve the intended test results or a device that does not provide a
final output that is a comprehensive interpretation of all parameter
(test output) results, a study evaluating the ability of device users
to correctly interpret results;
(vii) For any device indicated to guide blood product use, a
clinical outcome study determined to be acceptable by FDA that
specifically validates the device's indicated use in guiding blood
product use; and
(viii) For any device indicated to guide use of medication, a
clinical outcome study determined to be acceptable by FDA that
specifically validates the device's indicated use in guiding use of
medication.
(2) The labeling required under Sec. 809.10(b) of this chapter
must include the following:
(i) A summary of results from the study required by paragraph
(b)(1)(i) of this section, including repeatability, reproducibility,
and assessments of within-run, within-day, between-run, between-day,
between-reagent lot, between-instrument, between-site, and between-
operator precision, as applicable to the system.
(ii) The claimed measurement range of each parameter (test output),
as supported by demonstrated performance of the parameter (test output)
throughout the claimed measurement range, including studies required by
paragraphs (b)(1)(i) through (iii) and (v) of this section, and, if
applicable, paragraphs (b)(1)(vii) and (viii) of this section.
(iii) Identification of known interferents, including all
endogenous, exogenous, technology-specific, and patient population-
specific interferents, specific to each parameter (test output). The
information must include the concentration(s) or level(s) at which
interference was found to occur and the concentration range or levels
at which interference was not found to occur.
(iv) Information regarding the multisite clinical study required by
paragraph (b)(1)(v) of this section, including:
(A) Each patient population evaluated;
(B) Each intended use setting and the operators;
(C) A summary of the results, including the concordance analysis to
clinically relevant laboratory test(s); and
(D) Demonstrated expected (reference) values for each parameter
(test output).
(3) The labeling required under Sec. 809.10 of this chapter must
include the following:
(i) A limiting statement that the result(s) from the device is(are)
not intended to be used as the sole basis for a patient diagnosis.
(ii) Unless appropriate clinical outcome studies are done in
accordance with paragraph (b)(1)(vii) of this section that specifically
validate an indication for the device's use in guiding blood product
use, a limiting statement that the device has not been evaluated to
guide blood product use.
(iii) Unless appropriate clinical outcome studies are done in
accordance with paragraph (b)(1)(viii) of this section that
specifically validate an indication for the device's use in guiding use
of medication, a limiting statement that the device has not been
evaluated to guide use of medication.
Dated: May 5, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08151 Filed 5-8-25; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on May 9, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.