Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Liver Related Disease Progression, 2518-2520 [2023-00480]

Download as PDF 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: VerDate Sep<11>2014 15:51 Jan 13, 2023 Jkt 259001 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 PO 00000 Frm 00018 Fmt 4700 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 E:\FR\FM\17JAR1.SGM 17JAR1 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 VerDate Sep<11>2014 15:51 Jan 13, 2023 Jkt 259001 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 PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 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 17JAR1 2520 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) ............................................................................................................................... VerDate Sep<11>2014 15:51 Jan 13, 2023 Jkt 259001 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 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

[[Page 2520]]

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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