[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Rules and Regulations]
[Pages 35065-35067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15901]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA-2017-N-1620]
Medical Devices; Cardiovascular Devices; Classification of the
Adjunctive Cardiovascular Status Indicator
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
adjunctive cardiovascular status indicator into class II (special
controls). The special controls that will apply to the device are
identified in this order and will be part of the codified language for
the adjunctive cardiovascular status indicator's classification. The
Agency is classifying the device into class II (special controls) in
order to provide a reasonable assurance of safety and effectiveness of
the device.
DATES: This order is effective July 28, 2017. The classification was
applicable on December 21, 2016.
FOR FURTHER INFORMATION CONTACT: Nathalie Yarkony, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1254, Silver Spring, MD 20993-0002, 301-
796-1235, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval unless and until the device
is classified or reclassified into class I or II, or FDA issues an
order finding the device to be substantially equivalent, in accordance
with section 513(i) of the FD&C Act, to a predicate device that does
not require premarket approval. The Agency determines whether new
devices are substantially equivalent to predicate devices by means of
premarket notification procedures in section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
[[Page 35066]]
Section 513(f)(2) of the FD&C Act, also known as De Novo
classification, as amended by section 607 of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144), provides
two procedures by which a person may request FDA to classify a device
under the criteria set forth in section 513(a)(1). Under the first
procedure, the person submits a premarket notification under section
510(k) of the FD&C Act for a device that has not previously been
classified and, within 30 days of receiving an order classifying the
device into class III under section 513(f)(1) of the FD&C Act, the
person requests a classification under section 513(f)(2). Under the
second procedure, rather than first submitting a premarket notification
under section 510(k) of the FD&C Act and then a request for
classification under the first procedure, the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence and requests a classification under section
513(f)(2) of the FD&C Act. If the person submits a request to classify
the device under this second procedure, FDA may decline to undertake
the classification request if FDA identifies a legally marketed device
that could provide a reasonable basis for review of substantial
equivalence with the device or if FDA determines that the device
submitted is not of ``low-moderate risk'' or that general controls
would be inadequate to control the risks and special controls to
mitigate the risks cannot be developed.
In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
On May 24, 2016, Flashback Technologies submitted a request for
classification of the CipherOx CRI Tablet under section 513(f)(2) of
the FD&C Act.
In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies 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 to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
Therefore, on December 21, 2016, FDA issued an order to the
requestor classifying the device into class II. FDA is codifying the
classification of the device by adding Sec. 870.2200.
Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for an adjunctive
cardiovascular status indicator will need to comply with the special
controls named in this final order. A De Novo classification decreases
regulatory burdens. When FDA classifies a device type as class I or II
via the De Novo pathway, other manufacturers do not have to submit a De
Novo request or premarket approval application in order to market the
same type of device, unless the device has a new intended use or
technological characteristics that raise different questions of safety
or effectiveness. Instead, manufacturers can use the less burdensome
510(k) pathway, when necessary, to market their device, and the device
that was the subject of the original De Novo classification can serve
as a predicate device for additional 510(k)s from other manufacturers.
The device is assigned the generic name adjunctive cardiovascular
status indicator, and it is identified as a prescription device based
on sensor technology for the measurement of a physical parameter(s).
This device is intended for adjunctive use with other physical vital
sign parameters and patient information and is not intended to
independently direct therapy.
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--Adjunctive Cardiovascular Status Indicator Risks and Mitigation Measures
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Identified risk Mitigation measures
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Delayed or incorrect treatment due Software verification, validation, and hazard analysis.
to erroneous output as a result of Non-clinical performance testing.
software malfunction or algorithm Clinical performance testing.
error. Labeling.
Delayed or incorrect treatment due Usability assessment.
to user misinterpretation. Labeling.
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FDA believes that special controls, in combination with the general
controls, address these risks to health and provide reasonable
assurance of the safety and effectiveness.
Adjunctive cardiovascular status indicators are not safe for use
except under the supervision of a practitioner licensed by law to
direct the use of the device. As such, the device is a prescription
device and must satisfy prescription labeling requirements (see 21 CFR
801.109 Prescription devices).
Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k), if FDA determines that premarket notification is not necessary
to provide reasonable assurance of the safety and effectiveness of the
device. For this type of device, FDA believes premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device type and, therefore, is planning to exempt
the device from the premarket notification requirements under section
510(m) of the FD&C Act. Once finalized, persons who intend to market
this device type need not submit a 510(k) premarket notification
containing information on the adjunctive cardiovascular status
indicator prior to marketing the device.
II. 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.
III. Paperwork Reduction Act of 1995
This final administrative order establishes special controls that
refer to previously approved collections of
[[Page 35067]]
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, and the collections of information in 21 CFR part
801, regarding labeling have been approved under OMB control number
0910-0485.
List of Subjects in 21 CFR Part 870
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
870 is amended as follows:
PART 870--CARDIOVASCULAR DEVICES
0
1. The authority citation for part 870 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 870.2200 to subpart C to read as follows:
Sec. 870.2200 Adjunctive cardiovascular status indicator.
(a) Identification. The adjunctive cardiovascular status indicator
is a prescription device based on sensor technology for the measurement
of a physical parameter(s). This device is intended for adjunctive use
with other physical vital sign parameters and patient information and
is not intended to independently direct therapy.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Software description, verification, and validation based on
comprehensive hazard analysis must be provided, including:
(i) Full characterization of technical parameters of the software,
including any proprietary algorithm(s);
(ii) Description of the expected impact of all applicable sensor
acquisition hardware characteristics on performance and any associated
hardware specifications;
(iii) Specification of acceptable incoming sensor data quality
control measures; and
(iv) Mitigation of impact of user error or failure of any subsystem
components (signal detection and analysis, data display, and storage)
on accuracy of patient reports.
(2) Scientific justification for the validity of the status
indicator algorithm(s) must be provided. Verification of algorithm
calculations and validation testing of the algorithm using a data set
separate from the training data must demonstrate the validity of
modeling.
(3) Usability assessment must be provided to demonstrate that risk
of misinterpretation of the status indicator is appropriately
mitigated.
(4) Clinical data must be provided in support of the intended use
and include the following:
(i) Output measure(s) must be compared to an acceptable reference
method to demonstrate that the output measure(s) represent(s) the
predictive measure(s) that the device provides in an accurate and
reproducible manner;
(ii) The data set must be representative of the intended use
population for the device. Any selection criteria or limitations of the
samples must be fully described and justified;
(iii) Agreement of the measure(s) with the reference measure(s)
must be assessed across the full measurement range; and
(iv) Data must be provided within the clinical validation study or
using equivalent datasets to demonstrate the consistency of the output
and be representative of the range of data sources and data quality
likely to be encountered in the intended use population and relevant
use conditions in the intended use environment.
(5) Labeling must include the following:
(i) The type of sensor data used, including specification of
compatible sensors for data acquisition;
(ii) A description of what the device measures and outputs to the
user;
(iii) Warnings identifying sensor reading acquisition factors that
may impact measurement results;
(iv) Guidance for interpretation of the measurements, including
warning(s) specifying adjunctive use of the measurements;
(v) Key assumptions made in the calculation and determination of
measurements;
(vi) The measurement performance of the device for all presented
parameters, with appropriate confidence intervals, and the supporting
evidence for this performance; and
(vii) A detailed description of the patients studied in the
clinical validation (e.g., age, gender, race/ethnicity, clinical
stability) as well as procedural details of the clinical study.
Dated: July 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-15901 Filed 7-27-17; 8:45 am]
BILLING CODE 4164-01-P