[Federal Register Volume 90, Number 102 (Thursday, May 29, 2025)]
[Rules and Regulations]
[Pages 22634-22636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-09640]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA-2025-N-1163]
Medical Devices; Gastroenterology-Urology Devices; Classification
of the Temporarily-Placed Urethral Opening System for Symptoms of
Benign Prostatic Hyperplasia
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the temporarily-placed urethral opening system for symptoms
of benign prostatic hyperplasia 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 temporarily-
placed urethral opening system for symptoms of benign prostatic
hyperplasia'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, in part by reducing regulatory burdens.
DATES: This order is effective May 29, 2025. The classification was
applicable on February 25, 2020.
FOR FURTHER INFORMATION CONTACT: Mark Kreitz, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2630, Silver Spring, MD 20993-0002, 301-796-7019,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the temporarily-placed urethral
opening system for symptoms of benign prostatic hyperplasia 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, 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 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 (see 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 application
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 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
[[Page 22635]]
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 (21 U.S.C. 360c(a)(1)). 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 April 2, 2019, FDA received Medi-Tate Ltd.'s request for De Novo
classification of the iTind 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, 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 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 February 25, 2020, 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
876.5510.\1\ We have named the generic type of device temporarily-
placed urethral opening system for symptoms of benign prostatic
hyperplasia, and it is identified as a prescription use device that is
inserted transurethrally and deployed at the prostate. The implant is
designed to increase prostatic urethral patency by increasing prostatic
opening. It is intended for the treatment of symptoms due to urinary
outflow obstruction secondary to benign prostatic hyperplasia (BPH) in
men.
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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--Temporarily-Placed Urethral Opening System for Symptoms of
Benign Prostatic Hyperplasia Risks and Mitigation Measures
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Identified risks to health Mitigation measures
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Adverse tissue reaction................ Clinical performance testing,
Biocompatibility evaluation,
and Labeling.
Infection.............................. Clinical performance testing,
Sterilization validation,
Shelf life testing, and
Labeling.
Untreated symptoms due to device Clinical performance testing,
deployment failure. Non-clinical performance
testing, Shelf life testing,
and Labeling.
Bleeding, perforation, trauma, Clinical performance testing,
obstruction, incontinence, dysuria, Non-clinical performance
urgency due to device failure or testing, Shelf life testing,
difficult removal. Labeling.
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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) of the FD&C Act.
At the time of classification, temporarily-placed urethral opening
systems for symptoms of benign prostatic hyperplasia 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 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
[[Page 22636]]
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. 876.5510 to subpart F to read as follows:
Sec. 876.5510 Temporarily-placed urethral opening system for symptoms
of benign prostatic hyperplasia.
(a) Identification. A temporarily-placed urethral opening system
for symptoms of benign prostatic hyperplasia (BPH) is a prescription
use device that is inserted transurethrally and deployed at the
prostate. The implant is designed to increase prostatic urethral
patency by increasing prostatic opening. It is intended for the
treatment of symptoms due to urinary outflow obstruction secondary to
BPH in men.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical performance testing with the device under anticipated
conditions of use must evaluate improvement in urinary outflow symptoms
and document the adverse event profile.
(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, package integrity, and device
functionality over the labeled shelf life.
(5) 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) Deployment and removal; and
(ii) Mechanical strength.
(6) Labeling must include:
(i) Instructions for use, including the recommended training for
safe use of the device;
(ii) A summary of the clinical performance testing conducted with
the device, including device- and procedure-related adverse events; and
(iii) A shelf life.
Dated: May 22, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-09640 Filed 5-28-25; 8:45 am]
BILLING CODE 4164-01-P