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Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Rules and Regulations
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 513a1 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.
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 510ks see 21 U.S.C. 360cf2Bi.
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. 360ci, defining substantial equivalence. Instead, sponsors can use the less-burdensome 510k process, when necessary, to market their device.

II. De Novo Classification On July 30, 2018, NeuroSigma, Inc.
submitted a request for De Novo classification of the Monarch eTNS
System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513a1 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.
360ca1B. 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 19, 2019, FDA
issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21
CFR 882.5898.1 We have named the generic type of device transcutaneous electrical nerve stimulator for ADHD, and it is identified as a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.
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 1TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR ADHD RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Adverse tissue reaction
Injury or discomfort from electrical stimulation, including burns and nerve damage.

Biocompatibility evaluation.
Electromagnetic compatibility testing; Electrical, mechanical, and thermal safety testing; Non-clinical performance testing; Software verification, validation, and hazard analysis; Shelf life testing; and Labeling.
Labeling.

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Misuse that may result in device failure, user discomfort, or injury.
Skin irritation or infection from use on broken skin

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 510k of the FD&C Act.
At the time of classification, transcutaneous electrical nerve stimulators for ADHD are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502f1 of the FD&C Act and 21 CFR
801.5, as long as the conditions of 21
CFR 801.109 are met referring to 21
U.S.C. 352f1.

III. Analysis of Environmental Impact The Agency has determined under 21
CFR 25.34b 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.

1 FDA notes that the ACTION caption for this final order is styled as Final amendment; final order, rather than Final order. Beginning in December 2019, this editorial change was made to
indicate that the document amends the Code of Federal Regulations. The change was made in accordance with the Office of Federal Registers OFR interpretations of the Federal Register Act 44

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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. 35013521. 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 09100844; the collections of information in 21 CFR part 814,
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subparts A through E, regarding premarket approval, have been approved under OMB control number 09100231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 09100120; the collections of information in 21 CFR
part 820, regarding quality system regulation, have been approved under OMB control number 09100073; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control number 09100485.
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:

U.S.C. chapter 15, its implementing regulations 1
CFR 5.9 and parts 21 and 22, and the Document Drafting Handbook.

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