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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Rules and Regulations
68401

TABLE 1TRUNK AND LIMB ELECTRICAL STIMULATOR TO TREAT HEADACHE RISKS AND MITIGATION MEASURES
Continued Identified risks
Mitigation measures
Software malfunction leading to injury or discomfort e.g., tissue damage due to over-stimulation.
Hardware malfunction leading to injury or discomfort
Use error that may result in user discomfort, injury, or delay treatment for headaches.

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.
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.

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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 820, regarding quality system regulation, have been approved under OMB control number 09100073; the collections of information in 21 CFR part 814, 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; and the collections of information in part 801, regarding labeling, have been
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Software verification, validation, and hazard analysis.
Non-clinical performance testing, Shelf life testing, and Labeling.
Labeling.

approved under OMB control number 09100485.
List of Subjects in 21 CFR Part 882
Medical devices, Neurological 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 882NEUROLOGICAL 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 882.5899 to subpart F to read as follows:

882.5899 Trunk and limb electrical stimulator to treat headache.

a Identification. A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patients head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.
b Classification. Class II special controls. The special controls for this device are:
1 Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. This testing must include:
i Characterization of the electrical stimulation, including the following:
Waveforms; output modes; maximum output voltage and maximum output current at 500W, 2kW, and 10kW loads;
pulse duration; frequency; net charge per pulse; and maximum phase charge, maximum current density, maximum average current, and maximum average power density at 500W;
ii Characterization of the impedance monitoring system; and iii Characterization of the electrode performance including the electrical performance, adhesive integrity, shelflife, reusability, and current distribution of the electrode surface area.

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2 The patient-contacting components of the device must be demonstrated to be biocompatible.
3 Performance testing must demonstrate electromagnetic compatibility and electrical, mechanical, and thermal safety in the intended use environment.
4 Software verification, validation, and hazard analysis must be performed.
5 Labeling must include the following:
i Instructions for use, including the typical sensations experienced during treatment;
ii A detailed summary of the electrical stimulation output, and the device technical parameters, including any wireless specifications;
iii A shelf life for the electrodes and reuse information; and iv Instructions on care and cleaning of the device.
Dated: November 26, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202126175 Filed 12121; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Part 882
Docket No. FDA2021N0290

Medical Devices; Neurological Devices; Classification of the Conditioning Tool for Eating Disorders Food and Drug Administration, Department of Health and Human Services HHS.
ACTION: Final amendment; final order.
AGENCY:

The Food and Drug Administration FDA or we is classifying the conditioning tool for eating disorders 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 conditioning tool for eating disorders classification.
We are taking this action because we
SUMMARY:

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