Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingested, Transient, Space Occupying Device for Weight Management and/or Weight Loss, 70371-70373 [2021-26738]
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Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Rules and Regulations
effective September 15, 2021, is
amended as follows:
Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
*
*
*
*
*
ASO KY E5 Ashland, KY [Amended]
Ashland Regional Airport, KY
(Lat. 38°33′16″ N, long. 82°44′16″ W)
That airspace extending upward from 700
feet above the surface within a 6.5-mile
radius of the Ashland Regional Airport, and
extending 2 miles either side of the 098°
bearing from the airport extending from the
6.5-mile radius to 10.4 miles east of the
airport, and extending 2 miles either side of
the 278° bearing from the airport extending
from the 6.5-mile radius to 10.5 miles west
of the airport.
Issued in Fort Worth, Texas, on December
7, 2021.
Steven T. Phillips,
Acting Manager, Operations Support Group,
ATO Central Service Center.
[FR Doc. 2021–26785 Filed 12–9–21; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA–2021–N–0585]
Medical Devices; GastroenterologyUrology Devices; Classification of the
Ingested, Transient, Space Occupying
Device for Weight Management and/or
Weight Loss
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Final amendment; final order.
AGENCY:
The Food and Drug
Administration (FDA or we) is
classifying the ingested, transient, space
occupying device for weight
management and/or weight loss 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
ingested, transient, space occupying
device for weight management and/or
weight loss’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.
jspears on DSK121TN23PROD with RULES1
SUMMARY:
VerDate Sep<11>2014
15:55 Dec 09, 2021
Jkt 256001
This order is effective December
10, 2021. The classification was
applicable on April 12, 2019.
FOR FURTHER INFORMATION CONTACT:
April Marrone, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G218, Silver Spring,
MD 20993–0002, 240–402–6510,
April.Marrone@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
Upon request, FDA has classified the
ingested, transient, space occupying
device for weight management and/or
weight loss 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 (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
device 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
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
70371
(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 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 November 15, 2018, Gelesis, Inc.
submitted a request for De Novo
classification of the ingested, transient,
space occupying device for weight
management and/or weight loss. 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,
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
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10DER1
70372
Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Rules and Regulations
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 12, 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 876.5982.1 We have named the
generic type of device ingested,
transient, space occupying device for
weight management and/or weight loss,
and it is identified as an ingested
material that transiently occupies space
in the stomach. The device passes from
the body via the natural gastrointestinal
tract.
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—INGESTED, TRANSIENT, SPACE OCCUPYING DEVICE FOR WEIGHT MANAGEMENT AND/OR WEIGHT LOSS RISKS
AND MITIGATION MEASURES
Identified risks
Mitigation measures
Device related gastrointestinal adverse events, including:
• Obstruction
• Dilation
• Diarrhea
• Constipation
• Dehydration
Weight gain ...............................................................................................
Interaction with medication .......................................................................
Adverse tissue reaction ............................................................................
Infection ....................................................................................................
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).
At the time of classification, ingested,
transient, space occupying devices for
weight management and/or weight loss
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 (21 U.S.C.
352(f)(1)) and 21 CFR 801.5, as long as
the conditions of 21 CFR 801.109 are
met.
jspears on DSK121TN23PROD with RULES1
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.
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
VerDate Sep<11>2014
15:55 Dec 09, 2021
Jkt 256001
Clinical performance testing, Non-clinical performance testing, Labeling, and Shelf life testing.
Clinical performance testing, and Labeling.
Clinical performance testing, Non-clinical performance testing, and Labeling.
Biocompatibility evaluation.
Non-clinical performance testing, and Shelf life testing.
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 876
Medical devices.
indicate that the document ‘‘amends’’ the Code of
Federal Regulations. The change was made in
accordance with the Office of Federal Register’s
(OFR) interpretations of the Federal Register Act (44
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
Therefore, under the Federal Food,
Drug, and Cosmetic Act, and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 876 is
amended as follows:
PART 876—GASTROENTEROLOGYUROLOGY DEVICES
1. The authority citation for part 876
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 876.5982 to subpart F to read
as follows:
■
§ 876.5982 Ingested, transient, space
occupying device for weight management
and/or weight loss.
(a) Identification. This device is an
ingested material that transiently
occupies space in the stomach. The
device passes from the body via the
natural gastrointestinal tract.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) The patient-contacting
components of the device must be
demonstrated to be biocompatible for its
intended use.
(2) Non-clinical performance testing
must demonstrate that the device
performs as intended under anticipated
conditions for use, as follows:
(i) Performance bench testing in a
simulated use model must evaluate
device disintegration and device
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
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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:
VerDate Sep<11>2014
15:55 Dec 09, 2021
Jkt 256001
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
PO 00000
Frm 00025
Fmt 4700
Sfmt 4700
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,
E:\FR\FM\10DER1.SGM
10DER1
]]>Agencies
[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Rules and Regulations]
[Pages 70371-70373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26738]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA-2021-N-0585]
Medical Devices; Gastroenterology-Urology Devices; Classification
of the Ingested, Transient, Space Occupying Device for Weight
Management and/or Weight Loss
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Final amendment; final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the ingested, transient, space occupying device for weight management
and/or weight loss 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 ingested, transient,
space occupying device for weight management and/or weight loss'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 12, 2019.
FOR FURTHER INFORMATION CONTACT: April Marrone, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G218, Silver Spring, MD 20993-0002, 240-402-6510,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the ingested, transient, space
occupying device for weight management and/or weight loss 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 (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 device 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 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 November 15, 2018, Gelesis, Inc. submitted a request for De Novo
classification of the ingested, transient, space occupying device for
weight management and/or weight loss. 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, 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
[[Page 70372]]
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 12, 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
876.5982.\1\ We have named the generic type of device ingested,
transient, space occupying device for weight management and/or weight
loss, and it is identified as an ingested material that transiently
occupies space in the stomach. The device passes from the body via the
natural gastrointestinal tract.
---------------------------------------------------------------------------
\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
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--Ingested, Transient, Space Occupying Device for Weight
Management and/or Weight Loss Risks and Mitigation Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Device related gastrointestinal adverse Clinical performance testing,
events, including: Non-clinical performance
Obstruction................... testing, Labeling, and Shelf
Dilation...................... life testing.
Diarrhea
Constipation
Dehydration
Weight gain............................ Clinical performance testing,
and Labeling.
Interaction with medication............ Clinical performance testing,
Non-clinical performance
testing, and Labeling.
Adverse tissue reaction................ Biocompatibility evaluation.
Infection.............................. Non-clinical performance
testing, and Shelf life
testing.
------------------------------------------------------------------------
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).
At the time of classification, ingested, transient, space occupying
devices for weight management and/or weight loss 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 (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the
conditions of 21 CFR 801.109 are met.
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 876
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 876 is amended as follows:
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
0
1. The authority citation for part 876 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 876.5982 to subpart F to read as follows:
Sec. 876.5982 Ingested, transient, space occupying device for weight
management and/or weight loss.
(a) Identification. This device is an ingested material that
transiently occupies space in the stomach. The device passes from the
body via the natural gastrointestinal tract.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) The patient-contacting components of the device must be
demonstrated to be biocompatible for its intended use.
(2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions for use, as
follows:
(i) Performance bench testing in a simulated use model must
evaluate device disintegration and device
[[Page 70373]]
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
