Rule2026-18428
Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device
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Published
September 10, 2026
Effective
September 10, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the implanted tibial electrical urinary continence device 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 implanted tibial electrical urinary continence device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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 174 (Thursday, September 10, 2026)</title>
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[Federal Register Volume 91, Number 174 (Thursday, September 10, 2026)]
[Rules and Regulations]
[Pages 57504-57507]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18428]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA-2026-N-9908]
Medical Devices; Gastroenterology-Urology Devices; Classification
of the Implanted Tibial Electrical Urinary Continence Device
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
implanted tibial electrical urinary continence device 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 implanted tibial electrical urinary
continence device. We are taking this action because we have determined
that classifying the device into class II will provide a reasonable
assurance of the 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 September 10, 2026. The classification
was applicable on August 16, 2023.
FOR FURTHER INFORMATION CONTACT: Sharon Andrews, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2640, Silver Spring, MD 20993-0002, 301-796-6529,
<a href="/cdn-cgi/l/email-protection#d685beb7a4b9b8f897b8b2a4b3a1a596b0b2b7f8bebea5f8b1b9a0"><span class="__cf_email__" data-cfemail="d083b8b1a2bfbefe91beb4a2b5a7a390b6b4b1feb8b8a3feb7bfa6">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the implanted
tibial electrical urinary continence device into class II (special
controls), which we have determined will provide a reasonable assurance
of the safety and effectiveness of the device. In addition, we believe
this action will enhance
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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 October 5, 2022, FDA received BlueWind Medical Ltd.'s request
for De Novo classification of the Revi 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 the 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 16, 2023, 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
876.5305.\1\ We have named the generic type of device ``implanted
tibial electrical urinary continence device,'' and it is identified as
an implanted prescription device that receives power from a non-
implanted external power source to provide electrical stimulation of
the tibial nerve in proximity to the ankle. The device is intended for
the treatment of overactive bladder related symptoms of urge urinary
incontinence, urinary urgency, urinary frequency, and nocturia.
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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 Implanted Tibial
Electrical Urinary Continence Devices
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Identified risks to health Mitigation measures
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Overstimulation leading to nerve/tissue Non-clinical performance
damage. testing; Electromagnetic
compatibility testing;
Electrical safety testing;
Software verification,
validation, and hazard
analysis; Wireless coexistence
testing; and Labeling.
Adverse tissue reaction................ Biocompatibility evaluation;
and Labeling.
Infection.............................. Sterilization validation; Shelf-
life testing; and Labeling.
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Thermal injury......................... Non-clinical performance
testing; Thermal safety
testing; and Electrical safety
testing.
Interference with other medical devices Electromagnetic compatibility
testing; Magnetic resonance
compatibility testing;
Electrical safety testing;
Software verification,
validation and hazard
analysis; Wireless coexistence
testing; and Labeling.
Pain and discomfort.................... Non-clinical performance
testing; Electrical safety
testing; and Labeling.
Electrical shock or stimulation of non- Electrical safety testing;
target tissue. Electromagnetic compatibility
testing; and Labeling.
Mechanical injury to device or tissue/ Non-clinical performance
nerves. testing; and Labeling.
Undesired fluid retention due to use in Labeling.
inappropriate population.
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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 the 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.
At the time of classification, implanted tibial electrical urinary
continence devices 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.
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 implanted tibial
electrical urinary continence devices. 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. 876.5305 to subpart F to read as follows:
Sec. 876.5305 Implanted tibial electrical urinary continence device.
(a) Identification. An implanted tibial electrical urinary
continence device is an implanted prescription device that receives
power from a non-implanted external power source to provide electrical
stimulation of the tibial nerve in proximity to the ankle. The device
is intended for the treatment of overactive bladder related symptoms of
urge urinary incontinence, urinary urgency, urinary frequency, and
nocturia.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following testing must be conducted:
(i) Electrical performance testing of the device must be conducted
to validate the specified electrical output and duration of stimulation
of the device; and
(ii) Testing must verify the implant can withstand clinically
relevant forces during and after implantation.
(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 of patient-contacting components,
package integrity, and device functionality over the identified shelf
life.
(5) Performance testing must demonstrate the electromagnetic
compatibility, electrical safety, thermal safety, and wireless
performance of the device.
(6) Software verification, validation, and hazard analysis must be
performed.
(7) Performance testing must evaluate the compatibility of the
device in a magnetic resonance environment.
(8) Labeling for the device must include:
(i) A contraindication against use during pregnancy;
(ii) A contraindication against using the device in men who have
Benign Prostatic Hyperplasia (BPH) or other lower urinary tract
obstructions;
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(iii) A detailed summary of the device technical parameters and the
typical course of treatment;
(iv) Device- and procedure-related adverse events pertinent to use
of the device; and
(v) A shelf life for any sterile components.
(9) Patient labeling must include:
(i) Post-operative care instructions to avoid infection and
inflammation of the surgical site;
(ii) Instructions to avoid overstimulation related nerve and tissue
damage;
(iii) Instructions to avoid mechanical injuries to nerve and tissue
caused by the implanted component;
(iv) Instructions for reprocessing/cleaning of any reusable
components;
(v) Clinical performance reported by relevant subgroups;
(vi) The risks and benefits associated with use of the device;
(vii) Information on the typical course of treatment;
(viii) Instructions to avoid pain and discomfort; and
(ix) Instructions to avoid interference with other medical devices.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-18428 Filed 9-9-26; 8:45 am]
BILLING CODE 4164-01-P
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