[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,
[email protected].
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