Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Acute Kidney Injury Test System, 50071-50073 [2017-23491]
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Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (5
U.S.C. 601 et seq.), as amended by the
Small Business Regulatory Enforcement
and Fairness Act of 1996, requires an
agency to prepare and make available to
the public a regulatory flexibility
analysis that describes the effect of a
proposed rule on small entities (i.e.,
small businesses, small organizations,
and small governmental jurisdictions)
when the agency is required to publish
a general notice of proposed rulemaking
for a rule. As a notice of proposed
rulemaking is not necessary for this
rule, CBP is not required to prepare a
regulatory flexibility analysis for this
rule.
D. Signing Authority
This regulation is being issued in
accordance with 19 CFR 0.1(a)(1)
pertaining to the Secretary of the
Treasury’s authority (or that of his
delegate) to approve regulations related
to certain customs revenue functions.
List of Subjects in 19 CFR Part 12
Customs duties and inspection,
Reporting and recordkeeping
requirements.
Amendments to the Regulations
For the reasons set forth in the
preamble, part 12 of title 19 of the Code
of Federal Regulations (19 CFR part 12)
is amended as set forth below.
PART 12—SPECIAL CLASSES OF
MERCHANDISE
1. The general authority citation for
part 12 continues to read as follows:
■
Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202
(General Note 3(i), Harmonized Tariff
Schedule of the United States (HTSUS)),
1624.
*
*
*
*
*
2. The specific authority citation for
§ 12.151 is removed.
■
§ 12.151
nlaroche on DSK9F9SC42PROD with RULES
■
[Removed and Reserved]
3. Remove and reserve § 12.151.
Dated: October 25, 2017.
Kevin K. McAleenan,
Acting Commissioner, U.S. Customs and
Border Protection.
Approved:
Timothy E. Skud,
Deputy Assistant Secretary of the Treasury.
[FR Doc. 2017–23560 Filed 10–27–17; 8:45 am]
BILLING CODE 9111–14–P
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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.
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:
SUMMARY:
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
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
50071
(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
E:\FR\FM\30OCR1.SGM
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50072
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations
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® 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
Identified risks
Mitigation measures/21 CFR section
Incorrect interpretation of test results .......................................................
Special controls (1), (2), and (3) (21 CFR 862.1220(b)(1), 21 CFR
862.1220(b)(2), and 21 CFR 862.1220(b)(3)).
Special control (3) (21 CFR 862.1220(b)(3)).
Incorrect test results .................................................................................
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.
nlaroche on DSK9F9SC42PROD with RULES
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
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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
1. The authority citation for part 862
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 862.1220 to subpart B to read
as follows:
■
§ 862.1220
system.
Acute kidney injury test
(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
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
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.
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Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA–2017–N–5719]
Medical Devices; Immunology and
Microbiology Devices; Classification of
the Streptococcus SPP. Nucleic AcidBased Assay
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the Streptococcus spp.
nucleic acid-based assay 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
Streptococcus spp. nucleic acid-based
assay’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 April 16, 2014.
FOR FURTHER INFORMATION CONTACT:
Steven Tjoe, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4550, Silver Spring,
MD 20993–0002, 301–796–5866,
steven.tjoe@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
nlaroche on DSK9F9SC42PROD with RULES
SUMMARY:
I. Background
Upon request, FDA has classified the
Streptococcus spp. nucleic acid-based
assay 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
VerDate Sep<11>2014
13:41 Oct 27, 2017
Jkt 244001
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 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 (21 U.S.C. 360c(f)(2)). 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
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
50073
section 513(a)(1) of the FD&C Act (21
U.S.C. 360c(a)(1)). Although the device
was automatically 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
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 PMA 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
For this device, FDA issued an order
on March 20, 2014, finding the Lyra
Direct Strep Assay not substantially
equivalent to a predicate not subject to
a premarket application approval
(PMA). Thus, the device remained in
class III in accordance with section
513(f)(1) of the FD&C Act when we
issued the order.
On March 28, 2014, Quidel Corp.
submitted a request for De Novo
classification of the Lyra Direct Strep
Assay. 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 April 16, 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 866.2680. We
have named the generic type of device
Streptococcus spp. nucleic acid-based
assay, and it is identified as a qualitative
in vitro diagnostic device that is
intended to simultaneously detect and
E:\FR\FM\30OCR1.SGM
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Agencies
[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