Rule2026-10904
Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation
Primary source
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Published
June 1, 2026
Effective
June 1, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the orally ingested transient device for constipation 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 orally ingested transient device for constipation. 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 104 (Monday, June 1, 2026)</title>
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[Federal Register Volume 91, Number 104 (Monday, June 1, 2026)]
[Rules and Regulations]
[Pages 32347-32349]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10904]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA-2026-N-5196]
Medical Devices; Gastroenterology-Urology Devices; Classification
of the Orally Ingested Transient Device for Constipation
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
orally ingested transient device for constipation 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 orally ingested transient device for
constipation. 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 June 1, 2026. The classification was
applicable on August 26, 2022.
FOR FURTHER INFORMATION CONTACT: Joseph Nielsen, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2676, Silver Spring, MD 20993-0002, 301-796-6244,
<a href="/cdn-cgi/l/email-protection#bcf6d3cfd9ccd492f2d5d9d0cfd9d2fcdad8dd92d4d4cf92dbd3ca"><span class="__cf_email__" data-cfemail="95dffae6f0e5fdbbdbfcf0f9e6f0fbd5f3f1f4bbfdfde6bbf2fae3">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the orally
ingested transient device for constipation 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
[[Page 32348]]
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 November 30, 2021, FDA received Vibrant Ltd.'s request for De
Novo classification of the Vibrant System. 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 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 August 26, 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
876.5940.\1\ We have named the generic type of device ``orally ingested
transient device for constipation,'' and it is identified as an
electric swallowable capsule that naturally passes through the
gastrointestinal tract for the treatment of constipation.
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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 Orally Ingested
Transient Devices for Constipation
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Identified risks to health Mitigation measures
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Infection.............................. Bioburden testing;
Labeling; and
Shelf life testing.
Adverse tissue reaction................ Biocompatibility evaluation.
Device malfunction leading to injury... Electrical safety testing;
Software validation,
verification, and hazard
analysis;
Non-clinical performance
testing;
Labeling; and
Shelf life testing.
Interference with other devices........ Electromagnetic compatibility
testing.
Failure to excrete capsule............. Clinical data; and
Labeling.
Device related adverse events Clinical data;
including: Non-clinical performance
<bullet> Choking testing; and
<bullet> Abdominal pain Labeling.
<bullet> Abdominal distension
<bullet> Abdominal discomfort
<bullet> Vomiting
<bullet> Nausea
<bullet> Proctalgia
<bullet> Diarrhea
Device ineffective leading to Clinical data; and
constipation and effects of delayed Labeling.
treatment.
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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 orally ingested transient
devices for constipation. 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
[[Page 32349]]
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. 876.5940 to subpart F to read as follows:
Sec. 876.5940 Orally ingested transient device for constipation.
(a) Identification. An orally ingested transient device for
constipation is an electric swallowable capsule that naturally passes
through the gastrointestinal tract for the treatment of constipation.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical data must demonstrate the device performs as intended
and evaluate the following:
(i) Treatment of constipation; and
(ii) All adverse events.
(2) Non-clinical performance data must demonstrate that the device
performs as intended under anticipated conditions of use. The following
performance characteristics must be tested:
(i) Dimensional testing must verify device dimensions;
(ii) Performance bench testing must verify functional aspects of
the device design;
(iii) Leak testing must verify device integrity under worst case
clinical conditions;
(iv) Bite testing must demonstrate that the device can withstand
bite forces;
(v) pH resistance testing must evaluate integrity of the capsule
when exposed to a physiological relevant range of pH values; and
(vi) Bioburden testing must demonstrate the device does not pose an
infection risk throughout the labeled shelf life.
(3) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(4) Performance data must support the shelf life of the device by
demonstrating continued package integrity and device functionality over
the labeled shelf life.
(5) Software validation, verification, and hazard analysis must be
performed.
(6) Electrical safety and electromagnetic compatibility testing
must be performed for any electrical components of the device.
(7) Labeling for the device must include:
(i) A summary of clinical data for the device, including a
discussion of adverse events and clinical benefit; and
(ii) A shelf life.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-10904 Filed 5-29-26; 8:45 am]
BILLING CODE 4164-01-P
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