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Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Rules and Regulations
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 12, 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 876.5982.1 We have named the generic type of device ingested, transient, space occupying device for weight management and/or weight loss, and it is identified as an ingested material that transiently occupies space
in the stomach. The device passes from the body via the natural gastrointestinal tract.
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 1INGESTED, TRANSIENT, SPACE OCCUPYING DEVICE FOR WEIGHT MANAGEMENT AND/OR WEIGHT LOSS RISKS
AND MITIGATION MEASURES
Identified risks
Mitigation measures
Device related gastrointestinal adverse events, including:
Obstruction Dilation Diarrhea Constipation Dehydration Weight gain
Interaction with medication
Adverse tissue reaction
Infection

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.
At the time of classification, ingested, transient, space occupying devices for weight management and/or weight loss 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 21 U.S.C.
352f1 and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

jspears on DSK121TN23PROD 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.
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
VerDate Sep<11>2014

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Clinical performance testing, Non-clinical performance testing, Labeling, and Shelf life testing.

Clinical performance testing, and Labeling.
Clinical performance testing, Non-clinical performance testing, and Labeling.
Biocompatibility evaluation.
Non-clinical performance testing, and Shelf life testing.

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, 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 876
Medical devices.
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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Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows:
PART 876GASTROENTEROLOGYUROLOGY DEVICES
1. The authority citation for part 876
continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

2. Add 876.5982 to subpart F to read as follows:

876.5982 Ingested, transient, space occupying device for weight management and/or weight loss.

a Identification. This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.
b Classification. Class II special controls. The special controls for this device are:
1 The patient-contacting components of the device must be demonstrated to be biocompatible for its intended use.
2 Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, as follows:
i Performance bench testing in a simulated use model must evaluate device disintegration and device 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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