[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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
------------------------------------------------------------------------
         Identified risks                    Mitigation measures
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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


