Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Liver Related Disease Progression, 2518-2520 [2023-00480]
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2518
Federal Register / Vol. 88, No. 10 / Tuesday, January 17, 2023 / Rules and Regulations
carrying persons who have recently
traveled from, or were otherwise present
within, Uganda. These restrictions
funnel relevant arriving air passengers
to one of five designated airports of
entry where the U.S. is implementing
enhanced public health measures. Since
November 27, 2022, there have been no
new confirmed Ebola disease cases
reported in Uganda and two 21-day
incubation periods have passed. With
no new hospitalized patients with Ebola
disease, and no contacts of confirmed
Ebola disease cases still requiring
monitoring, the potential risk for
Ebolavirus exposure in Uganda has
greatly diminished. Therefore, flight
arrival restrictions are no longer
required for flights to the United States
carrying persons who have recently
traveled from, or were otherwise present
within, Uganda.
Notice of Termination of Arrival
Restrictions Applicable to All Flights
Carrying Persons Who Have Recently
Traveled From or Were Otherwise
Present Within Uganda
Pursuant to 6 U.S.C. 112(a), 19 U.S.C.
1433(c), and 19 CFR 122.32, and
effective as of 11:59 p.m. Eastern
Standard Time on January 11, 2023, for
all affected flights arriving at a United
States airport, I hereby terminate the
arrival restrictions applicable to flights
to the United States carrying persons
who have recently traveled from, or
were otherwise present within, Uganda
announced in the Arrival Restrictions
document published at 87 FR 61488
(October 12, 2022).
Alejandro Mayorkas,
Secretary, U.S. Department of Homeland
Security.
[FR Doc. 2023–00793 Filed 1–11–23; 4:45 pm]
BILLING CODE 9111–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
khammond on DSKJM1Z7X2PROD with RULES
[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.
The Food and Drug
Administration (FDA, Agency, or we) is
SUMMARY:
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15:51 Jan 13, 2023
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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,
Irene.Tebbs@fda.hhs.gov.
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
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Sfmt 4700
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
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Federal Register / Vol. 88, No. 10 / Tuesday, January 17, 2023 / Rules and Regulations
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
2519
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.
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
Identified risks
Mitigation measures
False negative results leading to delayed assessment or treatment.
False positive results leading to unnecessary
medical procedures.
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.
khammond on DSKJM1Z7X2PROD with RULES
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
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
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Certain
Certain
Certain
Certain
design verification and validation activities, including certain clinical studies; and
labeling information, including certain warnings and performance information.
design verification and validation activities, including certain clinical studies; and
labeling information, including certain warnings and performance information.
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
1. The authority citation for part 862
continues to read as follows:
■
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
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Fmt 4700
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Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 862.1622 to subpart B to read
as follows:
■
§ 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
U.S.C. chapter 15), its implementing regulations (1
CFR 5.9 and parts 21 and 22), and the Document
Drafting Handbook.
E:\FR\FM\17JAR1.SGM
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Federal Register / Vol. 88, No. 10 / Tuesday, January 17, 2023 / Rules and Regulations
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]
khammond on DSKJM1Z7X2PROD with RULES
BILLING CODE 4164–01–P
DEPARTMENT OF THE INTERIOR
Office of Natural Resources Revenue
30 CFR Part 1241
[Docket No. ONRR–2022–0003; DS63644000
DR2000000.CH7000 234D1113RT]
RIN 1012–AA35
2023 Civil Monetary Penalty Inflation
Adjustments
Office of Natural Resources
Revenue (‘‘ONRR’’), Interior.
ACTION: Final rule.
AGENCY:
Pursuant to the Federal Civil
Penalties Inflation Adjustment Act of
1990 (codified at 28 U.S.C. 2461 note),
as amended by the Federal Civil
Penalties Inflation Adjustment Act
Improvements Act of 2015 (referred to
herein as the ‘‘Inflation Adjustment
Acts’’), and Office of Management and
Budget (‘‘OMB’’) guidance, ONRR is
adjusting for inflation the civil monetary
penalty (‘‘CMP’’) amounts it assesses
under the Federal Oil and Gas Royalty
Management Act of 1982 (‘‘FOGRMA’’).
DATES: This rule is effective on January
13, 2023.
FOR FURTHER INFORMATION CONTACT: For
questions on procedural issues, contact
Luis Aguilar, Regulatory Specialist, by
telephone at (303) 231–3418 or by email
to Luis.Aguilar@onrr.gov. For questions
on technical issues, contact Michael
Marchetti, Enforcement Program
Manager, by telephone at (303) 231–
3125 or by email to Michael.Marchetti@
onrr.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
II. ONRR’s Inflation-Adjusted Maximum
Rates
III. Procedural Matters
A. Regulatory Planning and Review
(Executive Orders 12866 and 13563)
B. Regulatory Flexibility Act
C. Small Business Regulatory Enforcement
Fairness Act
D. Unfunded Mandates Reform Act
E. Takings (Executive Order 12630)
F. Federalism (Executive Order 13132)
G. Civil Justice Reform (Executive Order
12988)
H. Consultation With Indian Tribes
(Executive Order 13175)
I. Paperwork Reduction Act
J. National Environmental Policy Act
K. Effects on the Energy Supply (Executive
Order 13211)
L. Clarity of This Regulation
M. Administrative Procedure Act
I. Background
FOGRMA, at 30 U.S.C. 1719(a)–(d),
authorizes the Secretary of the Interior
(‘‘Secretary’’) to assess CMPs for royalty
reporting and other violations. Pursuant
to authority delegated to it by the
Secretary, ONRR published regulations
at 30 CFR part 1241 implementing the
Secretary’s CMP authority. The Inflation
Adjustment Acts (Pub. L. 114–74)
require Federal agencies to publish
annual CMP inflation adjustments in the
Federal Register by January 15th of each
year.
The Inflation Adjustment Acts and
OMB Memorandum No. M–23–05,
December 15, 2022 (‘‘OMB
Memorandum’’) specify that the annual
inflation adjustments are based on the
percent change between the Consumer
Price Index for all Urban Consumers
(‘‘CPI–U’’) published by the Department
of Labor for the month of October in the
year of the previous adjustment, and the
October CPI–U for the preceding year.
The OMB Memorandum further
specifies that the cost-of-living
adjustment multiplier for 2023, not
seasonally adjusted, is 1.07745 for CY
2023 (the October 2022 CPI–U (298.012)
divided by the October 2021 CPI–U
(276.589) = 1.07745). ONRR used this
guidance to calculate required inflation
adjustments. Pursuant to the Inflation
Adjustment Acts, any increases in CMPs
are rounded to the nearest whole dollar
and the new maximum penalty rates
apply to CMPs assessed after the date
the increase takes effect.
II. ONRR’s Inflation-Adjusted
Maximum Rates
This final rule increases the
maximum CMP dollar amounts for each
of the four violation categories
identified in 30 U.S.C. 1719(a)–(d) and
implemented by 30 CFR part 1241. The
following table identifies the applicable
ONRR regulations, the dollar amounts
set forth in the regulations, and the
adjusted amounts.
Current
maximum
penalty
30 CFR citation
1241.52(a)(2) ...............................................................................................................................
1241.52(b) ....................................................................................................................................
1241.60(b)(1) ...............................................................................................................................
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E:\FR\FM\17JAR1.SGM
$1,368
13,693
27,384
17JAR1
2023 inflation
adjustment
multiplier
1.07745
1.07745
1.07745
2023 adjusted
maximum
penalty
$1,474
14,754
29,505
Agencies
[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 [www.gpo.gov]
[FR Doc No: 2023-00480]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
[email protected].
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.
---------------------------------------------------------------------------
\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--Prognostic Test for Assessment of Liver Related Disease
Progression Risks and Mitigation Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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