[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]]
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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.
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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
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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
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Mitigation measures/21 CFR
Identified risks section
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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)).
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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
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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