[Federal Register Volume 87, Number 108 (Monday, June 6, 2022)]
[Rules and Regulations]
[Pages 34164-34166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12082]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA-2022-N-0790]
Medical Devices; Gastroenterology-Urology Devices; Classification
of the Non-Implanted Electrical Stimulation Device for Management of
Premature Ejaculation
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 non-implanted electrical stimulation device for
management of premature ejaculation 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 non-
implanted electrical stimulation device for management of premature
ejaculation'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.
[[Page 34165]]
DATES: This order is effective June 6, 2022. The classification was
applicable on November 23, 2021.
FOR FURTHER INFORMATION CONTACT: Feba Abraham, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2647, Silver Spring, MD 20993-0002, 307-796-5772,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the non-implanted electrical
stimulation device for management of premature ejaculation 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 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. 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 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 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 March 30, 2021, FDA received Virility Medical's request for De
Novo classification of the vPatch. 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 November 23, 2021, 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
876.5026.\1\ We have named the generic type of device non-implanted
electrical stimulation device for management of premature ejaculation,
and it is identified as a device intended to be used in patients with
premature ejaculation by delivery of electrical stimulation to the
perineal muscles and nerves.
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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--Non-Implanted Electrical Stimulation Device for Management of
Premature Ejaculation Risks and Mitigation Measures
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Identified risks to health Mitigation measures
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Use error leading to patient pain, Labeling.
discomfort, or injury.
Electrical, mechanical or thermal fault, Non-clinical performance
system malfunction, or other device testing;
failure resulting in lack of treatment or Electrical safety testing;
patient discomfort/injury (e.g., Electromagnetic
electrical shock, burn, tissue damage, or compatibility testing;
interference from other medical devices Software validation,
or electrical equipment). verification, and hazard
analysis;
Shelf-life testing; and
Labeling.
Adverse tissue reaction................... Biocompatibility evaluation,
and
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
[[Page 34166]]
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.
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 21 CFR 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 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. 876.5026 to subpart F to read as follows:
Sec. 876.5026 Non-implanted electrical stimulation device for
management of premature ejaculation.
(a) Identification. A non-implanted electrical stimulation device
for management of premature ejaculation is intended to be used in
patients with premature ejaculation by delivery of electrical
stimulation to the perineal muscles and nerves.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) The device must be demonstrated to be biocompatible.
(2) Performance testing must demonstrate the electromagnetic
compatibility, electrical safety, and thermal safety of the device.
(3) 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) Mechanical performance;
(ii) Electrical stimulation parameters; and
(iii) Battery performance.
(4) Performance testing must support shelf life by demonstrating
continued device functionality over the identified shelf life.
(5) Software verification, validation, and hazard analysis must be
performed.
(6) Labeling must include:
(i) Specific instructions regarding safe placement and correct use
of the device;
(ii) Warning(s) against use by patients with active implanted
medical devices; and
(iii) A shelf life.
Dated: May 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12082 Filed 6-3-22; 8:45 am]
BILLING CODE 4164-01-P