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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Rules and Regulations
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TABLE 1CONDITIONING TOOL FOR EATING DISORDERS RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Ineffective treatment leading to worsening condition of the patient, progression of disease, and/or delay of alternative treatments.
Adverse tissue reaction
Electrical shock or burns

Nonclinical performance testing; Software validation, verification and hazard analysis; and Labeling.
Biocompatibility evaluation.
Electrical safety testing, Electromagnetic compatibility EMC testing, 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. In order 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.
At the time of classification, conditioning tools for eating disorders 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.

lotter on DSK11XQN23PROD with RULES1

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.
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. 35013520. 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 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
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approved under OMB control number 09100120; and the collections of information in part 801, regarding labeling, have been approved under OMB control number 09100485.

Dated: November 26, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202126176 Filed 12121; 8:45 am BILLING CODE 416401P

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 882NEUROLOGICAL DEVICES

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Part 888
Docket No. FDA2021N0648

1. The authority citation for part 882
continues to read as follows:

Medical Devices; Orthopedic Devices;
Classification of the Intraoperative Orthopedic Strain Sensor
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

AGENCY:

2. Add 882.5060 to subpart F to read as follows:

882.5060
disorders.

Conditioning tool for eating
a Identification. A conditioning tool for eating disorders is a prescription device that non-invasively measures the mass of food eaten during a meal and provides feedback in the form of eating rate, patient satiety, and eating pattern information to the patient.
b Classification. Class II special controls. The special controls for this device are:
1 Nonclinical performance testing must demonstrate:
i Device measurement accuracy and repeatability; and ii Device feedback accuracy.
2 Software verification, validation, and hazard analysis must be performed.
3 The patient-contacting components of the device must be demonstrated to be biocompatible.
4 Performance testing must demonstrate the electromagnetic compatibility EMC and electrical safety of the device.
5 Labeling and patient labeling must be provided which includes the following:
i Information identifying and explaining how to use the device and its components; and ii Information on how the device operates and the typical course of treatment.

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Food and Drug Administration, Department of Health and Human Services HHS.
ACTION: Final amendment; final order.
The Food and Drug Administration FDA or we is classifying the intraoperative orthopedic strain sensor 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 intraoperative orthopedic strain sensors 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.
DATES: This order is effective December 2, 2021. The classification was applicable on March 28, 2019.
FOR FURTHER INFORMATION CONTACT:
Colin ONeill, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4458, Silver Spring, MD 209930002, 3017966428, Colin.ONeill@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:

I. Background Upon request, FDA has classified the intraoperative orthopedic strain sensor as class II special controls, which we have determined will provide a
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