[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Rules and Regulations]
[Pages 50071-50073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23491]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. FDA-2017-N-5685]


Medical Devices; Clinical Chemistry and Clinical Toxicology 
Devices; Classification of the Acute Kidney Injury Test System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the acute kidney injury test system 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 acute 
kidney injury test system'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, in part by reducing 
regulatory burdens.

DATES: This order is effective October 30, 2017. The classification was 
applicable on September 5, 2014.

FOR FURTHER INFORMATION CONTACT: Seth Olson, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4561, Silver Spring, MD 20993-0002, 301-796-4364, 
Jeremy.Olson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the acute kidney injury test 
system 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 (the 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 to a predicate device that does not require 
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new 
device is substantially equivalent to a predicate by means of the 
procedures for premarket notification under section 510(k) of the FD&C 
Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    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 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). 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

[[Page 50072]]

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 21 U.S.C. 360c(f)(2)(B)(i)). As a result, 
other device sponsors do not have to submit a De Novo request or 
premarket approval application in order to market a substantially 
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial 
equivalence''). Instead, sponsors can use the less-burdensome 510(k) 
process, when necessary, to market their device.

II. De Novo Classification

    On June 5, 2013, Astute Medical, Incorporated submitted a request 
for De Novo classification of the NEPHROCHECK[supreg] Test 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 general 
controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on September 5, 2014, FDA issued an order to the 
requestor classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 862.1220. We have named 
the generic type of device acute kidney injury test system, and it is 
identified as a device intended to measure one or more analytes in 
human samples as an aid in the assessment of a patient's risk for 
developing acute kidney injury. Test results are intended to be used in 
conjunction with other clinical and diagnostic findings, consistent 
with professional standards of practice, including confirmation by 
alternative methods.
    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--Acute Kidney Injury Test System Risks and Mitigation Measures
------------------------------------------------------------------------
                                            Mitigation measures/21 CFR
            Identified risks                         section
------------------------------------------------------------------------
Incorrect interpretation of test         Special controls (1), (2), and
 results.                                 (3) (21 CFR 862.1220(b)(1), 21
                                          CFR 862.1220(b)(2), and 21 CFR
                                          862.1220(b)(3)).
Incorrect test results.................  Special control (3) (21 CFR
                                          862.1220(b)(3)).
------------------------------------------------------------------------

    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. In order 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. 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. 3501-3520). 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 21 CFR part 801, regarding labeling have been approved 
under OMB control number 0910-0485; and the collections of information 
in 21 CFR part 820, regarding the Quality System Regulation have been 
approved under OMB control number 0910-0073.

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.  862.1220 to subpart B to read as follows:


Sec.  862.1220  Acute kidney injury test system.

    (a) Identification. An acute kidney injury test system is a device 
that is intended to measure one or more analytes in human samples as an 
aid in the assessment of a patient's risk for developing acute kidney 
injury. Test results are intended to be used in conjunction with other 
clinical and diagnostic findings, consistent with professional 
standards of practice, including confirmation by alternative methods.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must detail an appropriate 
end user device training program that will be offered while marketing 
the device as part of your efforts to mitigate the risk of incorrect 
interpretation of test results.
    (2) As part of the risk management activities performed as part of 
your 21 CFR 820.30 design controls, you must document the appropriate 
end user device training program provided in your premarket 
notification submission to satisfy special control 21 CFR 
862.1220(b)(1) that will be offered while marketing the device as part 
of your efforts to mitigate the risk of incorrect interpretation of 
test results.
    (3) Robust clinical data demonstrating the positive predictive 
value, negative predictive value, sensitivity and specificity of the 
test in the intended use population must be submitted as part of the 
premarket notification submission.


[[Page 50073]]


    Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23491 Filed 10-27-17; 8:45 am]
 BILLING CODE 4164-01-P