Rule2021-26741
Medical Devices; General and Plastic Surgery Devices; Classification of the Negative Pressure Wound Therapy Device for Reduction of Wound Complications
Primary source
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Published
December 10, 2021
Effective
December 10, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 235 (Friday, December 10, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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,
<a href="/cdn-cgi/l/email-protection#ce8db7a0baa6a7afe08da6afa0a98ea8aaafe0a6a6bde0a9a1b8"><span class="__cf_email__" data-cfemail="06457f68726e6f6728456e67686146606267286e6e7528616970">[email protected]</span></a>.
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,
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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;
<bullet> Mechanical failure............ Software verification,
<bullet> Software malfunction.......... validation, and hazard
<bullet> Use error..................... analysis; and Labeling.
Increase in wound complications due to Clinical data, Usability
use error. testing, and Labeling.
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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
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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
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