Medical Devices; General and Plastic Surgery Devices; Classification of the Negative Pressure Wound Therapy Device for Reduction of Wound Complications, 70373-70375 [2021-26741]
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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. 2021–26738 Filed 12–9–21; 8:45 am]
BILLING CODE 4164–01–P
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
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’
jspears on DSK121TN23PROD with RULES1
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 20993–0002, 301–796–6891,
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. 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
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70373
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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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.
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.
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
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
0910–0485.
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 25.34(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
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
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
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
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Clinical data, Usability testing, and Labeling.
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PART 878—GENERAL 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.
E:\FR\FM\10DER1.SGM
10DER1
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Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Rules and Regulations
for use with wound dressings classified
under § 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 patientcontacting 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;
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(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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA–2021–N–0595]
Medical Devices; Neurological
Devices; Classification of the
Transcutaneous Electrical Nerve
Stimulator for Attention Deficit
Hyperactivity Disorder
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Final amendment; final order.
AGENCY:
The Food and Drug
Administration (FDA, the Agency, or
we) is classifying the transcutaneous
electrical nerve stimulator for attention
deficit hyperactivity disorder (ADHD)
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
transcutaneous electrical nerve
stimulator for ADHD’s 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:
Pamela Scott, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4208, Silver Spring,
MD 20993–0002, 301–796–5433,
PamelaD.Scott@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Upon request, FDA has classified the
transcutaneous electrical nerve
stimulator for ADHD 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
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70375
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 (21
U.S.C. 360c(i)) to a predicate device that
does not require premarket approval.
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.
E:\FR\FM\10DER1.SGM
10DER1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
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
