Rule2021-26738
Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingested, Transient, Space Occupying Device for Weight Management and/or Weight Loss
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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 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.
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 70371-70373]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-26738]
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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.
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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,
<a href="/cdn-cgi/l/email-protection#a4e5d4d6cdc88ae9c5d6d6cbcac1e4c2c0c58accccd78ac3cbd2"><span class="__cf_email__" data-cfemail="a3e2d3d1cacf8deec2d1d1cccdc6e3c5c7c28dcbcbd08dc4ccd5">[email protected]</span></a>.
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
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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.
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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
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--Ingested, Transient, Space Occupying Device for Weight
Management and/or Weight Loss Risks and Mitigation Measures
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Identified risks Mitigation measures
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Device related gastrointestinal adverse Clinical performance testing,
events, including: Non-clinical performance
<bullet> Obstruction................... testing, Labeling, and Shelf
<bullet> Dilation...................... life testing.
<bullet> Diarrhea
<bullet> Constipation
<bullet> 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.
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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).
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
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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
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