Rule2026-10621
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 28, 2026
Effective
May 28, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the endoscopic suturing device for altering gastric anatomy for 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 classification of the endoscopic suturing device for altering gastric anatomy for weight loss. We are taking this action because we have determined that classifying the device into class II 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, in part by reducing regulatory burdens.
Full Text
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<title>Federal Register, Volume 91 Issue 102 (Thursday, May 28, 2026)</title>
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[Federal Register Volume 91, Number 102 (Thursday, May 28, 2026)]
[Rules and Regulations]
[Pages 31660-31662]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10621]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA-2026-N-5200]
Medical Devices; Gastroenterology-Urology Devices; Classification
of the Endoscopic Suturing Device for Altering Gastric Anatomy for
Weight Loss
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
endoscopic suturing device for altering gastric anatomy for 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 classification of the endoscopic suturing device
for altering gastric anatomy for weight loss. We are taking this action
because we have determined that classifying the device into class II
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, in part by reducing regulatory burdens.
DATES: This order is effective May 28, 2026. The classification was
applicable on July 12, 2022.
FOR FURTHER INFORMATION CONTACT: April Marrone, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5449, Silver Spring, MD 20993-0002, 240-402-6510,
<a href="/cdn-cgi/l/email-protection#85c4f5f7ece9abc8e4f7f7eaebe0c5e3e1e4abededf6abe2eaf3"><span class="__cf_email__" data-cfemail="622312100b0e4c2f0310100d0c07220406034c0a0a114c050d14">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the endoscopic
suturing device for altering gastric anatomy for weight loss into class
II (special controls), which we have determined will provide a
reasonable assurance of safety and effectiveness of the device. In
addition, we believe this action will enhance patients' access to
beneficial innovation, in part by reducing regulatory burdens 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 into, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (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 (see also part 860, subpart D (21 CFR part 860, subpart D)).
Section 207 of the Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-115) established the first procedure for De Novo
classification. Section 607 of the Food and Drug Administration Safety
and Innovation Act (Pub. L. 112-144) modified the De Novo
classification process by adding a second procedure. A device sponsor
may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a premarket
notification (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.
We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. 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 section 513(f)(2)(B)(i) of the
FD&C Act). 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 section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less burdensome 510(k) process, when necessary, to market their device.
II. De Novo Classification
On September 30, 2021, FDA received Apollo Endosurgery, Inc.'s
request for De Novo classification of the APOLLO ESG System, APOLLO ESG
SX System, APOLLO REVISE System, and APOLLO REVISE SX System devices.
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 of the device, 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 section 513(a)(1)(B) of the
FD&C Act). 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
[[Page 31661]]
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 July 12, 2022, 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
876.5983.\1\ We have named the generic type of device ``endoscopic
suturing device for altering gastric anatomy for weight loss,'' and it
is identified as a device that uses suturing to approximate gastric
tissue to restrict the volume of the stomach for the intended purpose
of weight loss.
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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 risks to health associated with this type of
device and the measures required to mitigate these risks in table 1.
Table 1--Risks to Health and Mitigation Measures for Endoscopic Suturing
Devices for Altering Gastric Anatomy for Weight Loss
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Identified risks to health Mitigation measures
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Device- and/or procedure-related Clinical performance testing;
adverse events, including: Non-clinical performance
<bullet> Death testing;
<bullet> Gastrointestinal bleeding Labeling;
<bullet> Obstruction Training;
<bullet> Perforation Sterilization validation; and
<bullet> Injury to organs adjacent to Shelf life testing.
the stomach
<bullet> Perigastric leak
<bullet> Nausea
<bullet> Infection
<bullet> Pain
<bullet> Pneumoperitoneum
<bullet> Pneumothorax
<bullet> Pulmonary embolism
Weight gain............................ Clinical performance testing
Labeling.
Adverse tissue reaction................ Biocompatibility evaluation.
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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 of the device. 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 final order.
Under the FD&C Act, submission of a premarket notification under
section 510(k) is required to reasonably assure the safety and
effectiveness of class II devices unless FDA determines that the device
type should be exempt under section 510(m) of the FD&C Act. At this
time FDA has not made this determination for endoscopic suturing
devices for altering gastric anatomy for weight loss. This device is
therefore subject to premarket notification requirements under section
510(k) of the FD&C Act.
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 normally 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 part 860, subpart D, regarding De Novo classification
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 management 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. 876.5983 to subpart F to read as follows:
Sec. 876.5983 Endoscopic suturing device for altering gastric anatomy
for weight loss.
(a) Identification. An endoscopic suturing device for altering
gastric anatomy for weight loss uses suturing to approximate gastric
tissue to restrict the volume of the stomach for the intended purpose
of weight loss.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical performance testing must demonstrate the device
performs as intended under anticipated conditions of use and evaluate
the following:
(i) Weight change; and
(ii) All adverse events.
[[Page 31662]]
(2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
(i) Performance bench testing in a simulated use model must verify
functional aspects of the device design and support device durability
during clinical use;
(ii) Dimensional specifications must be verified; and
(iii) Tensile strength testing must be performed for all
articulating components.
(3) Performance data must support the shelf life of the device by
demonstrating continued package integrity and device functionality over
the labeled shelf life.
(4) Performance data must demonstrate the sterility of the patient-
contacting components of the device.
(5) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(6) Training must be provided so that, upon completion of the
training program, the user can use the device correctly to approximate
tissue to alter the gastric anatomy for the purpose of weight loss with
minimal impact to the safety of the patient.
(7) Labeling must include:
(i) A summary of clinical performance testing with the device,
including a discussion of adverse events and clinical benefit reported
as percent total body weight loss; and
(ii) A shelf life.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-10621 Filed 5-27-26; 8:45 am]
BILLING CODE 4164-01-P
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