Rule2023-00480
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Liver Related Disease Progression
Primary source
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Published
January 17, 2023
Effective
January 17, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the prognostic test for assessment of liver related disease progression 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 prognostic test for assessment of liver related disease progression's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Full Text
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<title>Federal Register, Volume 88 Issue 10 (Tuesday, January 17, 2023)</title>
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[Federal Register Volume 88, Number 10 (Tuesday, January 17, 2023)]
[Rules and Regulations]
[Pages 2518-2520]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-00480]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
[Docket No. FDA-2022-N-3335]
Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of the Prognostic Test for Assessment of Liver
Related Disease Progression
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 prognostic test for assessment of liver related disease
progression 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 prognostic test for assessment of
liver related disease progression'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 January 17, 2023. The classification was
applicable on August 20, 2021.
FOR FURTHER INFORMATION CONTACT: Irene Tebbs, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3526, Silver Spring, MD 20993-0002, 340-402-0283,
<a href="/cdn-cgi/l/email-protection#69201b0c070c473d0c0b0b1a290f0d084701011a470e061f"><span class="__cf_email__" data-cfemail="bbf2c9ded5de95efded9d9c8fbdddfda95d3d3c895dcd4cd">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the prognostic test for assessment
of liver related disease progression 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 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. 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
less-burdensome 510(k) process, when necessary, to market their device.
II. De Novo Classification
On November 4, 2020, FDA received Siemens Healthcare Diagnostics
Inc.'s request for De Novo classification of the ADVIA Centaur Enhanced
Liver Fibrosis. FDA reviewed the request in order to classify the
device under the
[[Page 2519]]
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 20, 2021, 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
862.1622.\1\ We have named the generic type of device prognostic test
for assessment of liver related disease progression, and it is
identified as a device intended to measure one or more analytes
obtained from human samples as an aid in assessing progression of liver
related disease. This device is not intended for diagnosis of any
disease, for monitoring the effect of any therapeutic product, for
assessing progression to hepatocellular carcinoma, or for assessing
disease progression in individuals with viral hepatitis. It is also not
intended for the detection of viruses, viral antigens, or antibodies to
viruses.
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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--Prognostic Test for Assessment of Liver Related Disease
Progression Risks and Mitigation Measures
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Identified risks Mitigation measures
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False negative results Certain design verification and
leading to delayed validation activities, including certain
assessment or treatment. clinical studies; and
Certain labeling information, including
certain warnings and performance
information.
False positive results Certain design verification and
leading to unnecessary validation activities, including certain
medical procedures. clinical studies; and
Certain labeling information, including
certain warnings and performance
information.
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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 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 parts 801and 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. 862.1622 to subpart B to read as follows:
Sec. 862.1622 Prognostic test for assessment of liver related
disease progression.
(a) Identification. A prognostic test for assessment of liver
related disease progression is intended to measure one or more analytes
obtained from human samples as an aid in assessing progression of liver
related disease. This device is not intended for diagnosis of any
disease, for monitoring the effect of any therapeutic product, for
assessing progression to hepatocellular carcinoma, or for assessing
disease progression in individuals with viral hepatitis. It is also not
intended for the detection of viruses, viral antigens, or antibodies to
viruses.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Design verification and validation must include clinical
validation data providing:
(i) Information demonstrating clinical performance in a population
of patients with liver disease for the different risk categories (e.g.,
at lower risk, at higher risk) for progression of their disease using
well characterized clinical specimens representing the intended use
population collected from multiple
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intended clinical sites, or an alternative study design determined to
be appropriate by FDA.
(ii) Information demonstrating that the outcomes measured and the
length of followup are clinically relevant for the progression of the
specified liver disease.
(iii) Information demonstrating that the clinical criteria for
determining whether the target disease is present and that the
exclusion and inclusion criteria for subjects who have the target
disease are appropriate.
(iv) Information demonstrating test performance of the complete
test system, including any sample collection and processing steps.
(v) Information, provided or referenced, generated in samples from
non-diseased individuals, that demonstrate the upper and lower
reference intervals for the output provided by the device.
(2) The labeling required under 21 CFR 809.10(b) must include:
(i) A warning statement that test results are not intended to
diagnose disease or for monitoring the effect of any therapeutic
product.
(ii) A warning statement that test results are intended to be used
in conjunction with other clinical and diagnostic findings, consistent
with professional standards of practice, including information obtained
by alternative methods, and clinical evaluation, as appropriate.
(iii) A warning statement that describes any limitations on the
clinical interpretation(s) of the test results.
(iv) Detailed information on device performance, including any
limitations to the data generated in the clinical study(ies) and
information on device performance in relevant subgroups (e.g., severity
of liver disease at the beginning of the observation period) observed
in the clinical study(ies).
(v) Information on the analytical performance of the device,
including demonstration of reproducibility across multiple sites and
multiple reagent lots, or an alternative reproducibility study design
determined to be appropriate by FDA.
Dated: January 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00480 Filed 1-13-23; 8:45 am]
BILLING CODE 4164-01-P
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