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Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Rules and Regulations hydration state throughout the gastrointestinal tract;
ii Bioburden and moisture content assessments must evaluate device infection risk throughout the labeled shelf life; and iii Performance data must support the shelf life of the device by demonstrating continued package integrity and device functionality over the labeled shelf life.
3 Clinical performance testing must demonstrate the device performs as intended and evaluate the following:
i Weight change;
ii All adverse events, including obstruction, dilation, diarrhea, constipation, and dehydration; and iii Interaction with representative medications.
4 Physician and patient device labeling must state:
i The clinical benefit of the device as assessed by using percent total body weight loss;
ii Treatment must be offered in combination with diet and exercise;
iii Instructions on how to use the device as intended including how to avoid interaction with medication; and iv The shelf life of the device.
Dated: December 6, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202126738 Filed 12921; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Part 878
Docket No. FDA2021N0572

Medical Devices; General and Plastic Surgery Devices; Classification of the Negative Pressure Wound Therapy Device for Reduction of Wound Complications Food and Drug Administration, Department of Health and Human Services HHS.
ACTION: Final amendment; final order.
AGENCY:

The Food and Drug Administration FDA, Agency, or we is classifying the negative pressure wound therapy device for reduction of wound complications 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 negative pressure wound therapy device for reduction of wound complications
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SUMMARY:

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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 10, 2021. The classification was applicable on April 19, 2019.
FOR FURTHER INFORMATION CONTACT:
Cynthia Chang, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4646, Silver Spring, MD 209930002, 3017966891, Cynthia.Chang@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background Upon request, FDA has classified the negative pressure wound therapy device for reduction of wound complications as class II special controls, which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients access to beneficial innovation, by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III
occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device.
Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device see 21 U.S.C. 360cf1. We refer to these devices as postamendments devices because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act FD&C Act.
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513i of the FD&C Act to a predicate device that does not require premarket approval see 21 U.S.C.
360ci. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510k of the FD&C Act 21 U.S.C.
360k and part 807 21 CFR part 807.
FDA may also classify a device through De Novo classification, a common name for the process authorized under section 513f2 of the
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FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification Pub. L. 105
115. Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure Pub. L. 112144. A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510k for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513f1 of the FD&C Act, the person then requests a classification under section 513f2.
Under the second procedure, rather than first submitting a 510k and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513f2 of the FD&C Act.
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 in order 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 March 15, 2018, KCI USA, Inc.
submitted a request for De Novo classification of the PREVENA 125 and PREVENA PLUS 125 Therapy Units.
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,
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