Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analyte(s) in Human Clinical Specimens To Aid in Assessment of Patients With Suspected Sepsis, 49098-49100 [2017-22994]
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49098
Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA–2017–N–5657]
Medical Devices; Immunology and
Microbiology Devices; Classification of
the Device To Detect and Measure
Non-Microbial Analyte(s) in Human
Clinical Specimens To Aid in
Assessment of Patients With
Suspected Sepsis
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the device to detect and
measure non-microbial analyte(s) in
human clinical specimens to aid in
assessment of patients with suspected
sepsis 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 device to detect and measure
non-microbial analyte(s) in human
clinical specimens to aid in assessment
of patients with suspected sepsis’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
24, 2017. The classification was
applicable on February 20, 2016.
FOR FURTHER INFORMATION CONTACT:
Ryan Lubert, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4545, Silver Spring,
MD 20993–0002, 240–402–6357,
Ryan.Lubert@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
pmangrum on DSK3GDR082PROD with RULES
I. Background
Upon request, FDA has classified the
device to detect and measure nonmicrobial analyte(s) in human clinical
specimens to aid in assessment of
patients with suspected sepsis 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
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Jkt 244001
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
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Sfmt 4700
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
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 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 March 4, 2015, B·R·A·H·M·S
GmbH, part of Thermo Fisher Scientific,
submitted a request for De Novo
classification of the B·R·A·H·M·S PCT
sensitive KRYPTOR. 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 February 20, 2016, 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 866.3215. We
have named the generic type of device,
device to detect and measure nonmicrobial analyte(s) in human clinical
specimens to aid in assessment of
patients with suspected sepsis, and it is
identified as an in vitro device intended
for the detection and qualitative and/or
quantitative measurement of one or
more non-microbial analytes in human
clinical specimens to aid in the
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Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Rules and Regulations
assessment of patients with suspected
sepsis when used in conjunction with
clinical signs and symptoms and other
clinical and laboratory findings.
FDA has identified the following risks
to health associated specifically with
49099
this type of device and the measures
required to mitigate these risks in table
1.
TABLE 1—DEVICE TO DETECT AND MEASURE NON-MICROBIAL ANALYTE(S) IN HUMAN CLINICAL SPECIMENS TO AID IN
ASSESSMENT OF PATIENTS WITH SUSPECTED SEPSIS RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures/21 CFR section
Incorrect determination of procalcitonin (PCT) value, including false
positives and false negatives, by the device can lead to improper patient management.
Incorrect interpretation of device results by end user can lead to improper patient management.
Special Controls (2), (3), and (7) (21 CFR 866.3215(b)(2); 21 CFR
866.3215(b)(3); and 21 CFR 866.3215(b)(7)).
Manual calculation error of final 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.
pmangrum on DSK3GDR082PROD 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. 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 in part 820 have been
approved under OMB control number
0910–0073, and the collections of
information in 21 CFR parts 801 and
809 regarding labeling have been
approved under OMB control number
0910–0485.
List of Subjects in 21 CFR Part 866
Biologics, Laboratories, Medical
devices.
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Special Controls (1), (4), (5), (6), and (7) (21 CFR 866.3215(b)(1); 21
CFR 866.3215(b)(4); 21 CFR 866.3215(b)(5); 21 CFR
866.3215(b)(6); and 21 CFR 866.3215(b)(7)).
Special Control (7) (21 CFR 866.3215(b)(7)).
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 866 is
amended as follows:
PART 866—IMMUNOLOGY AND
MICROBIOLOGY DEVICES
1. The authority citation for part 866
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 866.3215 to subpart D to read
as follows:
■
§ 866.3215 Device to detect and measure
non-microbial analyte(s) in human clinical
specimens to aid in assessment of patients
with suspected sepsis.
(a) Identification. A device to detect
and measure non-microbial analyte(s) in
human clinical specimens to aid in
assessment of patients with suspected
sepsis is identified as an in vitro device
intended for the detection and
qualitative and/or quantitative
measurement of one or more nonmicrobial analytes in human clinical
specimens to aid in the assessment of
patients with suspected sepsis when
used in conjunction with clinical signs
and symptoms and other clinical and
laboratory findings.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Premarket notification
submissions must include the device’s
detailed Indications for Use statement
describing what the device detects and
measures, the results provided to the
user, whether the measure is qualitative
and/or quantitative, the clinical
indications for which the test is to be
used, and the specific population(s) for
which the device use is intended.
(2) Premarket notification
submissions must include detailed
documentation of the device
description, including (as applicable),
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all device components, software,
ancillary reagents required but not
provided, explanation of the device
principle and methodology, and for
molecular devices include detailed
documentation of the primer/probe
sequence, design, and rationale for
sequence selection.
(3) Premarket notification
submissions must include detailed
documentation of applicable analytical
studies, such as, analytical sensitivity
(Limit of Detection, Limit of Blank, and
Limit of Quantitation), precision,
reproducibility, analytical measuring
range, interference, cross-reactivity, and
specimen stability.
(4) Premarket notification
submissions must include detailed
documentation of a prospective clinical
study or, if appropriate, results from an
equivalent sample set. This detailed
documentation must include the
following information:
(i) Results must demonstrate adequate
device performance relative to a wellaccepted comparator.
(ii) Clinical sample results must
demonstrate consistency of device
output throughout the device measuring
range likely to be encountered in the
Intended Use population.
(iii) Clinical study documentation
must include the original study protocol
(including predefined statistical
analysis plan), study report
documenting support for the Indications
for Use(s), and results of all statistical
analyses.
(5) Premarket notification
submissions must include evaluation of
the level of the non-microbial analyte in
asymptomatic patients with
demographic characteristics (e.g., age,
racial, ethnic, and gender distribution)
similar to the Intended Use population.
(6) As part of the risk management
activities performed under 21 CFR
820.30 design controls, you must
document an appropriate end user
device training program that will be
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Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Rules and Regulations
offered as part of your efforts to mitigate
the risk of failure to correctly operate
the instrument.
(7) A detailed explanation of the
interpretation of results and acceptance
criteria must be included in the device’s
21 CFR 809.10(b)(9) compliant labeling,
and a detailed explanation of the
interpretation of the limitations of the
samples (e.g., collected on day of
diagnosis) must be included in the
device’s 21 CFR 809.10(b)(10) compliant
labeling.
Dated: October 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–22994 Filed 10–23–17; 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–5290]
Medical Devices; Immunology and
Microbiology Devices; Classification of
the Mass Spectrometer System for
Clinical Use for the Identification of
Microorganisms
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the mass spectrometer
system for clinical use for the
identification of microorganisms 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
mass spectrometer system for clinical
use for the identification of
microorganisms’ 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
24, 2017. The classification was
applicable on August 21, 2013.
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,
pmangrum on DSK3GDR082PROD with RULES
SUMMARY:
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MD 20993–0002, 301–796–5866,
steven.tjoe@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the
mass spectrometer system for clinical
use for the identification of
microorganisms 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
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
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 shall 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
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 (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
´
On January 3, 2013, bioMerieux, Inc.
submitted a request for De Novo
classification of the Vitek® MS. 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.
E:\FR\FM\24OCR1.SGM
24OCR1
]]>Agencies
[Federal Register Volume 82, Number 204 (Tuesday, October 24, 2017)]
[Rules and Regulations]
[Pages 49098-49100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22994]
[[Page 49098]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2017-N-5657]
Medical Devices; Immunology and Microbiology Devices;
Classification of the Device To Detect and Measure Non-Microbial
Analyte(s) in Human Clinical Specimens To Aid in Assessment of Patients
With Suspected Sepsis
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the device to detect and measure non-microbial analyte(s) in human
clinical specimens to aid in assessment of patients with suspected
sepsis 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 device to detect and measure non-
microbial analyte(s) in human clinical specimens to aid in assessment
of patients with suspected sepsis'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 24, 2017. The classification was
applicable on February 20, 2016.
FOR FURTHER INFORMATION CONTACT: Ryan Lubert, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4545, Silver Spring, MD 20993-0002, 240-402-6357,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the device to detect and measure
non-microbial analyte(s) in human clinical specimens to aid in
assessment of patients with suspected sepsis 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 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 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 March 4, 2015, B[middot]R[middot]A[middot]H[middot]M[middot]S
GmbH, part of Thermo Fisher Scientific, submitted a request for De Novo
classification of the B[middot]R[middot]A[middot]H[middot]M[middot]S
PCT sensitive KRYPTOR. 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 February 20, 2016, 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 866.3215. We have named
the generic type of device, device to detect and measure non-microbial
analyte(s) in human clinical specimens to aid in assessment of patients
with suspected sepsis, and it is identified as an in vitro device
intended for the detection and qualitative and/or quantitative
measurement of one or more non-microbial analytes in human clinical
specimens to aid in the
[[Page 49099]]
assessment of patients with suspected sepsis when used in conjunction
with clinical signs and symptoms and other clinical and laboratory
findings.
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--Device To Detect and Measure Non-Microbial Analyte(s) in Human
Clinical Specimens To Aid in Assessment of Patients With Suspected
Sepsis Risks and Mitigation Measures
------------------------------------------------------------------------
Mitigation measures/21 CFR
Identified risks section
------------------------------------------------------------------------
Incorrect determination of Special Controls (2), (3), and
procalcitonin (PCT) value, including (7) (21 CFR 866.3215(b)(2); 21
false positives and false negatives, CFR 866.3215(b)(3); and 21 CFR
by the device can lead to improper 866.3215(b)(7)).
patient management.
Incorrect interpretation of device Special Controls (1), (4), (5),
results by end user can lead to (6), and (7) (21 CFR
improper patient management. 866.3215(b)(1); 21 CFR
866.3215(b)(4); 21 CFR
866.3215(b)(5); 21 CFR
866.3215(b)(6); and 21 CFR
866.3215(b)(7)).
Manual calculation error of final Special Control (7) (21 CFR
results. 866.3215(b)(7)).
------------------------------------------------------------------------
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 in part 820 have been approved under OMB control number
0910-0073, and the collections of information in 21 CFR parts 801 and
809 regarding labeling have been approved under OMB control number
0910-0485.
List of Subjects in 21 CFR Part 866
Biologics, Laboratories, 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
866 is amended as follows:
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
0
1. The authority citation for part 866 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 866.3215 to subpart D to read as follows:
Sec. 866.3215 Device to detect and measure non-microbial analyte(s)
in human clinical specimens to aid in assessment of patients with
suspected sepsis.
(a) Identification. A device to detect and measure non-microbial
analyte(s) in human clinical specimens to aid in assessment of patients
with suspected sepsis is identified as an in vitro device intended for
the detection and qualitative and/or quantitative measurement of one or
more non-microbial analytes in human clinical specimens to aid in the
assessment of patients with suspected sepsis when used in conjunction
with clinical signs and symptoms and other clinical and laboratory
findings.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Premarket notification submissions must include the device's
detailed Indications for Use statement describing what the device
detects and measures, the results provided to the user, whether the
measure is qualitative and/or quantitative, the clinical indications
for which the test is to be used, and the specific population(s) for
which the device use is intended.
(2) Premarket notification submissions must include detailed
documentation of the device description, including (as applicable), all
device components, software, ancillary reagents required but not
provided, explanation of the device principle and methodology, and for
molecular devices include detailed documentation of the primer/probe
sequence, design, and rationale for sequence selection.
(3) Premarket notification submissions must include detailed
documentation of applicable analytical studies, such as, analytical
sensitivity (Limit of Detection, Limit of Blank, and Limit of
Quantitation), precision, reproducibility, analytical measuring range,
interference, cross-reactivity, and specimen stability.
(4) Premarket notification submissions must include detailed
documentation of a prospective clinical study or, if appropriate,
results from an equivalent sample set. This detailed documentation must
include the following information:
(i) Results must demonstrate adequate device performance relative
to a well-accepted comparator.
(ii) Clinical sample results must demonstrate consistency of device
output throughout the device measuring range likely to be encountered
in the Intended Use population.
(iii) Clinical study documentation must include the original study
protocol (including predefined statistical analysis plan), study report
documenting support for the Indications for Use(s), and results of all
statistical analyses.
(5) Premarket notification submissions must include evaluation of
the level of the non-microbial analyte in asymptomatic patients with
demographic characteristics (e.g., age, racial, ethnic, and gender
distribution) similar to the Intended Use population.
(6) As part of the risk management activities performed under 21
CFR 820.30 design controls, you must document an appropriate end user
device training program that will be
[[Page 49100]]
offered as part of your efforts to mitigate the risk of failure to
correctly operate the instrument.
(7) A detailed explanation of the interpretation of results and
acceptance criteria must be included in the device's 21 CFR
809.10(b)(9) compliant labeling, and a detailed explanation of the
interpretation of the limitations of the samples (e.g., collected on
day of diagnosis) must be included in the device's 21 CFR 809.10(b)(10)
compliant labeling.
Dated: October 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-22994 Filed 10-23-17; 8:45 am]
BILLING CODE 4164-01-P
