[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Rules and Regulations]
[Pages 52315-52316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22695]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA-2018-N-3635]
Medical Devices; Neurological Devices; Classification of the
External Upper Limb Tremor Stimulator
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 external upper limb tremor stimulator 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 external upper limb tremor stimulator'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 17, 2018. The classification was
applicable on April 26, 2018.
FOR FURTHER INFORMATION CONTACT: Kristen Bowsher, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2646, Silver Spring, MD 20993-0002, 301-
796-6448, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the external upper limb tremor
stimulator 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 (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 (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. 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 (21
U.S.C. 360(k)) and part 807 (21 CFR part 807).
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 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. 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 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 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 May 17, 2017, Cala Health, Inc. submitted a request for De Novo
classification of the Cala ONE. 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 the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on April 26, 2018, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 882.5897. We have named
the generic type of device external upper limb tremor stimulator, and
it is identified as a prescription device that is placed externally on
the upper limb and designed to aid in
[[Page 52316]]
tremor symptom relief of the upper limb.
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--External Upper Limb Tremor Stimulator Risks and Mitigation
Measures
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Identified risks Mitigation measures
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Tissue damage due to over- Non-clinical performance testing;
stimulation. Software verification, validation,
and hazard analysis; Electrical
safety testing; Shelf life testing;
and Labeling.
Adverse tissue reaction........... Biocompatibility evaluation and
Labeling.
Electrical shock or burn.......... Electrical, thermal, and mechanical
safety testing; Software
verification, validation, and
hazard analysis; and Labeling.
Interference with other devices... Electromagnetic compatibility (EMC)
testing; Software verification,
validation, and hazard analysis;
and Labeling.
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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. 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.
At the time of classification, external upper limb tremor
stimulators are for prescription use only. Prescription devices are
exempt from the requirement for adequate directions for use for the
layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1))
and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met
(referring to 21 U.S.C. 352(f)(1)).
III. Analysis of Environmental Impact
We have 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 and guidance. 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 the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in 21 CFR part 820, regarding
quality system regulations, have been approved under OMB control number
0910-0073; 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 882
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
882 is amended as follows:
PART 882--NEUROLOGICAL DEVICES
0
1. The authority citation for part 882 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 882.5897 to subpart F to read as follows:
Sec. 882.5897 External upper limb tremor stimulator.
(a) Identification. An external upper limb tremor stimulator is a
prescription device which is placed externally on the upper limb and
designed to aid in tremor symptom relief of the upper limb.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Non-clinical performance testing must assess the following:
(i) Characterization of the electrical stimulation, including the
following, must be performed: Waveforms, output modes, maximum output
voltage, maximum output current, pulse duration, frequency, net charge
per pulse, maximum phase charge at 500 ohms, maximum current density,
maximum average current, and maximum average power density.
(ii) Impedance testing, current distribution across the electrode
surface area, adhesive integrity, and shelf life testing of the
electrodes and gels must be conducted.
(iii) Simulated use testing of sensor performance and the
associated algorithms that determine the stimulation output must be
conducted.
(2) Patient-contacting components of the device must be
demonstrated to be biocompatible.
(3) Performance testing must demonstrate electrical, thermal, and
mechanical safety along with electromagnetic compatibility (EMC) of the
device in the intended use environment.
(4) Software verification, validation, and hazard analysis must be
performed.
(5) Physician and patient labeling must include:
(i) Summaries of electrical stimulation parameters;
(ii) Instructions on how to correctly use and maintain the device;
(iii) Instructions and explanations of all user-interface
components;
(iv) Instructions on how to clean the device;
(v) A shelf life for the electrodes and gel; and
(vi) Reuse information.
Dated: October 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22695 Filed 10-16-18; 8:45 am]
BILLING CODE 4164-01-P