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Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Rules and Regulations
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 878.4783.1 We have named the generic type of device negative pressure wound therapy device for reduction of wound complications, and it is identified as a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the
wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under 21
CFR 878.4780. This classification does not include devices intended for organ space wounds.
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 1NEGATIVE PRESSURE WOUND THERAPY DEVICE FOR REDUCTION OF WOUND COMPLICATIONS RISKS AND
MITIGATION MEASURES
Identified risks
Mitigation measures
Adverse tissue reaction
Infection
Electrical shock or electromagnetic interference with other devices

Biocompatibility evaluation.
Sterilization validation, Shelf life testing, and Labeling.
Electromagnetic compatibility testing, Electrical safety testing, and Labeling.
Clinical data; Non-clinical performance testing; Usability testing; Shelf life testing; Software verification, validation, and hazard analysis; and Labeling.

Damage to underlying tissue e.g., wound maceration, uncontrolled bleeding due to:
Mechanical failure Software malfunction Use error Increase in wound complications due to use error

nor an environmental impact statement is required.

approved under OMB control number 09100485.

IV. Paperwork Reduction Act of 1995

List of Subjects in 21 CFR Part 878
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 878 is amended as follows:

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
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
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 the Federal Registers OFR interpretations of the Federal Register Act 44

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, negative pressure wound therapy devices for reduction of wound complications 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
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Clinical data, Usability testing, and Labeling.

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PART 878GENERAL AND PLASTIC
SURGERY DEVICES
1. The authority citation for part 878
continues to read as follows:

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

2. Add 878.4783 to subpart E to read as follows:

878.4783 Negative pressure wound therapy device for reduction of wound complications.

a Identification. A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended 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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