[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