52315 Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Rules and Regulations 
software applications and hardware- 
based devices that incorporate software. 
(7) The risk management activities 
performed as part of the manufacturer’s 21 CFR 820.30 design controls must document an appropriate end user device training program that will be offered as part of efforts to mitigate the risk of failure to correctly operate the instrument. 
Dated: October 12, 2018. 
Leslie Kux, 
Associate Commissioner for Policy. 
[FR Doc. 2018–22694 Filed 10–16–18; 8:45 am] 
BILLING CODE 4164–01–P 
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, Kristen.Bowsher@fda.hhs.gov. 
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 
VerDate Sep<11>2014 16:09 Oct 16, 2018 Jkt 247001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\17OCR1.SGM 17OCR1daltland on DSKBBV9HB2PROD with RULES52316 Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Rules and Regulations 
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—E XTERNAL UPPER LIMBTREMOR STIMULATOR RISKS AND MITIGATION MEASURES  
Identified risks Mitigation measures 
Tissue damage due to over-stimu-
lation.Non-clinical performance testing; 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 La-
beling. 
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 
■1. The authority citation for part 882 
continues to read as follows: 
Authority: 21 U.S.C. 351, 360, 360c, 360e, 
360j, 360l, 371. 
■2. Add § 882.5897 to subpart F to read 
as follows: 
§ 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 
VerDate Sep<11>2014 16:09 Oct 16, 2018 Jkt 247001 PO 00000 Frm 00012 Fmt 4700 Sfmt 9990 E:\FR\FM\17OCR1.SGM 17OCR1daltland on DSKBBV9HB2PROD with RULES