[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Rules and Regulations]
[Pages 70373-70375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26741]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2021-N-0572]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Negative Pressure Wound Therapy Device for 
Reduction of Wound Complications

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final amendment; final order.

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SUMMARY: 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' 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 20993-0002, 301-796-6891, 
[email protected].

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. 
360c(f)(1)). 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 
513(i) of the FD&C Act to a predicate device that does not require 
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new 
device is substantially equivalent to a predicate by means of the 
procedures for premarket notification under section 510(k) of the FD&C 
Act (21 U.S.C. 360(k)) 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 513(f)(2) of the 
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. 112-144). A device sponsor may 
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device 
that has not previously been classified. After receiving an order from 
FDA classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person then requests a classification under section 
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
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 513(f)(2) 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 
513(a)(1) 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 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). 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. 360c(i), defining ``substantial 
equivalence''). Instead, sponsors can use the less-burdensome 510(k) 
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 513(a)(1) 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,

[[Page 70374]]

provide reasonable assurance of the safety and effectiveness of the 
device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). 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.
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    \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 Register's (OFR) interpretations of the Federal Register 
Act (44 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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    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 1--Negative Pressure Wound Therapy Device for Reduction of Wound
               Complications Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Adverse tissue reaction................  Biocompatibility evaluation.
Infection..............................  Sterilization validation, Shelf
                                          life testing, and Labeling.
Electrical shock or electromagnetic      Electromagnetic compatibility
 interference with other devices.         testing, Electrical safety
                                          testing, and Labeling.
Damage to underlying tissue (e.g.,       Clinical data; Non-clinical
 wound maceration, uncontrolled           performance testing; Usability
 bleeding) due to:                        testing; Shelf life testing;
 Mechanical failure............   Software verification,
 Software malfunction..........   validation, and hazard
 Use error.....................   analysis; and Labeling.
Increase in wound complications due to   Clinical data, Usability
 use error.                               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. 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 510(k) 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 502(f)(1) 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. 352(f)(1)).

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) 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. 3501-3521). 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 0910-0844; the collections of 
information in 21 CFR part 814, subparts A through E, regarding 
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding 
premarket notification submissions, have been approved under OMB 
control number 0910-0120; the collections of information in 21 CFR part 
820, regarding quality system regulation, have been approved under OMB 
control number 0910-0073; and the collections of information in 21 CFR 
part 801, regarding labeling, have been approved under OMB control 
number 0910-0485.

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:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

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


0
2. Add Sec.  878.4783 to subpart E to read as follows:


Sec.  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

[[Page 70375]]

for use with wound dressings classified under Sec.  878.4780. This 
classification does not include devices intended for organ space 
wounds.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical data must demonstrate that the device performs as 
intended under anticipated conditions of use and evaluate the 
following:
    (i) Wound complication rates; and
    (ii) All adverse events.
    (2) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (3) Performance data must demonstrate the sterility of the patient-
contacting components of the device.
    (4) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the labeled shelf life.
    (5) Usability testing must demonstrate that intended users can 
correctly use the device, based solely on reading the instructions for 
use.
    (6) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested in a worst-case scenario for 
the intended use life:
    (i) Ability to maintain pressure levels at the wound site under a 
worst-case scenario for the intended use life;
    (ii) Fluid removal rate consistent with the wound types specified 
in the indications for use; and
    (iii) Timely triggering of all alarms.
    (7) Performance data must demonstrate the electrical safety and 
electromagnetic compatibility (EMC) of the device.
    (8) Software verification, validation, and hazard analysis must be 
performed.
    (9) Labeling must include the following:
    (i) Instructions for use;
    (ii) A summary of the device technical specifications, including 
pressure settings, modes (e.g., continuous or intermittent), alarms, 
and safety features;
    (iii) Compatible components and devices;
    (iv) A summary of the clinical evidence for the indications for 
use;
    (v) A shelf life for sterile components; and
    (vi) Use life and intended use environments.
    (10) For devices intended for use outside of a healthcare facility, 
patient labeling must include the following:
    (i) Information on how to operate the device and its components and 
the typical course of treatment;
    (ii) Information on when to contact a healthcare professional; and
    (iii) Use life.

    Dated: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26741 Filed 12-9-21; 8:45 am]
BILLING CODE 4164-01-P


