80 FR 35842 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation; Republication

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 120 (June 23, 2015)

Page Range		35842-35843
FR Document		2015-15328

The Food and Drug Administration (FDA) is republishing in its entirety a final order entitled ``Medical Devices; Gastroenterology- Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation'' that published in the Federal Register on May 28, 2015 (80 FR 30353). FDA is republishing to correct an inadvertent omission of information. FDA is classifying the vibrator for climax control of premature ejaculation into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the classification of the vibrator for climax control of premature ejaculation. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Federal Register, Volume 80 Issue 120 (Tuesday, June 23, 2015)

[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Rules and Regulations]
[Pages 35842-35843]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-15328]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2015-N-1297]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Vibrator for Climax Control of Premature Ejaculation; 
Republication

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order; republication.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is republishing in its 
entirety a final order entitled ``Medical Devices; Gastroenterology-
Urology Devices; Classification of the Vibrator for Climax Control of 
Premature Ejaculation'' that published in the Federal Register on May 
28, 2015 (80 FR 30353). FDA is republishing to correct an inadvertent 
omission of information. FDA is classifying the vibrator for climax 
control of premature ejaculation into class II (special controls). The 
special controls that will apply to the device are identified in this 
order and will be part of the codified language for the classification 
of the vibrator for climax control of premature ejaculation. The Agency 
is classifying the device into class II (special controls) in order to 
provide a reasonable assurance of safety and effectiveness of the 
device.

DATES: This order is effective June 23, 2015. The classification was 
applicable on March 20, 2015.

FOR FURTHER INFORMATION CONTACT: Tuan Nguyen, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G118, Silver Spring, MD 20993-0002, 301-796-5174, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were 
not in commercial distribution before May 28, 1976 (the date of 
enactment of the Medical Device Amendments of 1976), generally referred 
to as postamendments devices, are classified automatically by statute 
into class III without any FDA rulemaking process. These devices remain 
in class III and require premarket approval, unless and until the 
device is classified or reclassified into class I or II, or FDA issues 
an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the FD&C Act, to a predicate device 
that does not require premarket approval. The Agency determines whether 
new devices are substantially equivalent to predicate devices by means 
of premarket notification procedures in section 510(k) of the FD&C Act 
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the 
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to 
classify a device under the criteria set forth in section 513(a)(1). 
Under the first procedure, the person submits a premarket notification 
under section 510(k) of the FD&C Act for a device that has not 
previously been classified and, within 30 days of receiving an order 
classifying the device into class III under section 513(f)(1) of the 
FD&C Act, the person requests a classification under section 513(f)(2). 
Under the second procedure, rather than first submitting a premarket 
notification under section 510(k) of the FD&C Act and then a request 
for classification under the first procedure, the person determines 
that there is no legally marketed device upon which to base a 
determination of substantial equivalence and requests a classification 
under section 513(f)(2) of the FD&C Act. If the person submits a 
request to classify the device under this second procedure, FDA may 
decline to undertake the classification request if FDA identifies a 
legally marketed device that could provide a reasonable basis for 
review of substantial equivalence with the device or if FDA determines 
that the device submitted is not of ``low-moderate risk'' or that 
general controls would be inadequate to control the risks and special 
controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either 
procedure provided by section 513(f)(2) of the FD&C Act, FDA will 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device. On 
November 21, 2013, Auris Medtech Europe, Ltd., submitted a request for 
classification of the Prolong^TM under section 513(f)(2) of 
the FD&C Act. The manufacturer recommended that the device be 
classified into class II (Ref. 1). On June 17, 2014, the request for 
classification of Prolong^TM was transferred from Auris 
Medtech Europe, Ltd., to Ergon Medical, Ltd., through an amendment to 
the request (Ref. 2).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the request in order to classify the device under the criteria for 
classification set forth in section 513(a)(1). FDA classifies 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 to provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use. After review of the information submitted in the 
request, FDA determined that the device can be classified into class II 
with the establishment of special controls. FDA believes these special 
controls, in addition to general controls, will provide reasonable 
assurance of the safety and effectiveness of the device.
    Therefore, on March 20, 2015, FDA issued an order to the requestor 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 876.5025.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a vibrator 
for climax control of premature ejaculation will need to comply with 
the special controls named in this final order. The device is assigned 
the generic name vibrator for climax control of premature ejaculation, 
and it is identified as a device used for males who suffer from 
premature ejaculation. It is designed to increase the time between 
arousal and ejaculation using the stimulating vibratory effects of the 
device on the penis.
    FDA has identified the following risks to health associated 
specifically with this type of device, as well as the measures required 
to mitigate these risks in table 1.

[[Page 35843]]



 Table 1--Vibrator for Climax Control of Premature Ejaculation Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risk                    Mitigation measures
------------------------------------------------------------------------
Pain or Discomfort due to Misuse of      Labeling.
 Device.
Burns..................................  Electrical and Thermal Safety
                                          Testing Labeling.
Electrical Shock.......................  Electrical Safety Testing
                                          Labeling.
Adverse Skin Reactions.................  Biocompatibility Testing.
Patient Injury due to Device Breakage    Mechanical Safety Testing
 or Failure.                              Labeling.
Interference With Other Devices/         Electromagnetic Compatibility
 Electrical Equipment.                    Testing Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in combination 
with the general controls, address these risks to health and provide 
reasonable assurance of the safety and effectiveness:
     The labeling must include specific instructions regarding 
the proper placement and use of the device.
     The portions of the device that contact the patient must 
be demonstrated to be biocompatible.
     Appropriate analysis/testing must demonstrate 
electromagnetic compatibility safety, electrical safety, and thermal 
safety of the device.
     Mechanical safety testing must demonstrate that the device 
will withstand forces encountered during use.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) of the FD&C Act, if FDA determines that premarket notification 
is not necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For this type of device, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Therefore, this device type is not exempt from premarket notification 
requirements. Persons who intend to market this type of device must 
submit to FDA a premarket notification, prior to marketing the device, 
which contains information about the vibrator for climax control of 
premature ejaculation they intend to market.

II. 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.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations. 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. 3501-3520). The collections of information in 
part 807, subpart E, regarding premarket notification submissions have 
been approved under OMB control number 0910-0120, and the collections 
of information in 21 CFR part 801, regarding labeling have been 
approved under OMB control number 0910-0485.

IV. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov.

    1. DEN130047: De Novo Request per 513(f)(2) from Auris Medtech 
Europe Ltd., dated November 21, 2013.
    2. Amendment to De Novo Request from Auris Medtech Europe Ltd., 
dated June 17, 2014.

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 21 CFR part 876 continues to read as 
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Republish Sec.  876.5025 to read as follows:


Sec.  876.5025  Vibrator for climax control of premature ejaculation.

    (a) Identification. A vibrator for climax control of premature 
ejaculation is used for males who suffer from premature ejaculation. It 
is designed to increase the time between arousal and ejaculation using 
the stimulating vibratory effects of the device on the penis.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The labeling must include specific instructions regarding the 
proper placement and use of the device.
    (2) The portions of the device that contact the patient must be 
demonstrated to be biocompatible.
    (3) Appropriate analysis/testing must demonstrate electromagnetic 
compatibility safety, electrical safety, and thermal safety of the 
device.
    (4) Mechanical safety testing must demonstrate that the device will 
withstand forces encountered during use.

    Dated: June 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15328 Filed 6-22-15; 8:45 am]
 BILLING CODE 4164-01-P

35842 Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Rules and Regulations

Dated: June 18, 2015. commercial distribution before May 28, by section 513(f)(2) of the FD&C Act,
Leslie Kux, 1976 (the date of enactment of the FDA will classify the device by written
Associate Commissioner for Policy. Medical Device Amendments of 1976), order within 120 days. This
[FR Doc. 2015–15388 Filed 6–22–15; 8:45 am] generally referred to as postamendments classification will be the initial
BILLING CODE 4164–01–P devices, are classified automatically by classification of the device. On
statute into class III without any FDA November 21, 2013, Auris Medtech
rulemaking process. These devices Europe, Ltd., submitted a request for
DEPARTMENT OF HEALTH AND remain in class III and require classification of the ProlongTM under
HUMAN SERVICES premarket approval, unless and until section 513(f)(2) of the FD&C Act. The
the device is classified or reclassified manufacturer recommended that the
Food and Drug Administration into class I or II, or FDA issues an order device be classified into class II (Ref. 1).
finding the device to be substantially On June 17, 2014, the request for
21 CFR Part 876 equivalent, in accordance with section classification of ProlongTM was
[Docket No. FDA–2015–N–1297] 513(i) of the FD&C Act, to a predicate transferred from Auris Medtech Europe,
device that does not require premarket Ltd., to Ergon Medical, Ltd., through an
Medical Devices; Gastroenterology- approval. The Agency determines amendment to the request (Ref. 2).
Urology Devices; Classification of the whether new devices are substantially
equivalent to predicate devices by In accordance with section 513(f)(2) of
Vibrator for Climax Control of
means of premarket notification the FD&C Act, FDA reviewed the
Premature Ejaculation; Republication
procedures in section 510(k) of the request in order to classify the device
AGENCY: Food and Drug Administration, FD&C Act (21 U.S.C. 360(k)) and part under the criteria for classification set
HHS. 807 (21 CFR part 807) of the regulations. forth in section 513(a)(1). FDA classifies
ACTION: Final order; republication. Section 513(f)(2) of the FD&C Act, as devices into class II if general controls
amended by section 607 of the Food and by themselves are insufficient to
SUMMARY: The Food and Drug Drug Administration Safety and provide reasonable assurance of safety
Administration (FDA) is republishing in Innovation Act (Pub. L. 112–144), and effectiveness, but there is sufficient
its entirety a final order entitled provides two procedures by which a information to establish special controls
‘‘Medical Devices; Gastroenterology- person may request FDA to classify a to provide reasonable assurance of the
Urology Devices; Classification of the device under the criteria set forth in safety and effectiveness of the device for
Vibrator for Climax Control of section 513(a)(1). Under the first its intended use. After review of the
Premature Ejaculation’’ that published procedure, the person submits a information submitted in the request,
in the Federal Register on May 28, 2015 premarket notification under section FDA determined that the device can be
(80 FR 30353). FDA is republishing to 510(k) of the FD&C Act for a device that classified into class II with the
correct an inadvertent omission of has not previously been classified and, establishment of special controls. FDA
information. FDA is classifying the within 30 days of receiving an order believes these special controls, in
vibrator for climax control of premature classifying the device into class III addition to general controls, will
ejaculation into class II (special under section 513(f)(1) of the FD&C Act, provide reasonable assurance of the
controls). The special controls that will the person requests a classification safety and effectiveness of the device.
apply to the device are identified in this under section 513(f)(2). Under the Therefore, on March 20, 2015, FDA
order and will be part of the codified second procedure, rather than first issued an order to the requestor
language for the classification of the submitting a premarket notification classifying the device into class II. FDA
vibrator for climax control of premature under section 510(k) of the FD&C Act is codifying the classification of the
ejaculation. The Agency is classifying and then a request for classification device by adding 21 CFR 876.5025.
the device into class II (special controls) under the first procedure, the person
in order to provide a reasonable determines that there is no legally Following the effective date of this
assurance of safety and effectiveness of marketed device upon which to base a final classification order, any firm
the device. determination of substantial submitting a premarket notification
DATES: This order is effective June 23, equivalence and requests a classification (510(k)) for a vibrator for climax control
2015. The classification was applicable under section 513(f)(2) of the FD&C Act. of premature ejaculation will need to
on March 20, 2015. If the person submits a request to comply with the special controls named
FOR FURTHER INFORMATION CONTACT: classify the device under this second in this final order. The device is
Tuan Nguyen, Center for Devices and procedure, FDA may decline to assigned the generic name vibrator for
Radiological Health, Food and Drug undertake the classification request if climax control of premature ejaculation,
Administration, 10903 New Hampshire FDA identifies a legally marketed device and it is identified as a device used for
Ave., Bldg. 66, Rm. G118, Silver Spring, that could provide a reasonable basis for males who suffer from premature
MD 20993–0002, 301–796–5174, review of substantial equivalence with ejaculation. It is designed to increase the
tuan.nguyen@fda.hhs.gov. the device or if FDA determines that the time between arousal and ejaculation
device submitted is not of ‘‘low- using the stimulating vibratory effects of
SUPPLEMENTARY INFORMATION:
moderate risk’’ or that general controls the device on the penis.
I. Background would be inadequate to control the risks FDA has identified the following risks
In accordance with section 513(f)(1) of and special controls to mitigate the risks to health associated specifically with
the Federal Food, Drug, and Cosmetic cannot be developed. this type of device, as well as the
mstockstill on DSK4VPTVN1PROD with RULES

Act (the FD&C Act) (21 U.S.C. In response to a request to classify a measures required to mitigate these
360c(f)(1)), devices that were not in device under either procedure provided risks in table 1.

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Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Rules and Regulations 35843

TABLE 1—VIBRATOR FOR CLIMAX CONTROL OF PREMATURE EJACULATION RISKS AND MITIGATION MEASURES
Identified risk Mitigation measures

Pain or Discomfort due to Misuse of Device ........................................... Labeling.
Burns ........................................................................................................ Electrical and Thermal Safety Testing Labeling.
Electrical Shock ........................................................................................ Electrical Safety Testing Labeling.
Adverse Skin Reactions ........................................................................... Biocompatibility Testing.
Patient Injury due to Device Breakage or Failure .................................... Mechanical Safety Testing Labeling.
Interference With Other Devices/Electrical Equipment ............................ Electromagnetic Compatibility Testing Labeling.

FDA believes that the following found in other FDA regulations. These vibratory effects of the device on the
special controls, in combination with collections of information are subject to penis.
the general controls, address these risks review by the Office of Management and (b) Classification. Class II (special
to health and provide reasonable Budget (OMB) under the Paperwork controls). The special controls for this
assurance of the safety and Reduction Act of 1995 (44 U.S.C. 3501– device are:
effectiveness: 3520). The collections of information in (1) The labeling must include specific
• The labeling must include specific part 807, subpart E, regarding premarket instructions regarding the proper
instructions regarding the proper notification submissions have been placement and use of the device.
placement and use of the device. approved under OMB control number (2) The portions of the device that
• The portions of the device that 0910–0120, and the collections of contact the patient must be
contact the patient must be information in 21 CFR part 801, demonstrated to be biocompatible.
demonstrated to be biocompatible. regarding labeling have been approved (3) Appropriate analysis/testing must
• Appropriate analysis/testing must under OMB control number 0910–0485. demonstrate electromagnetic
demonstrate electromagnetic compatibility safety, electrical safety,
IV. References
compatibility safety, electrical safety, and thermal safety of the device.
and thermal safety of the device. The following references have been (4) Mechanical safety testing must
• Mechanical safety testing must placed on display in the Division of demonstrate that the device will
demonstrate that the device will Dockets Management (HFA–305), Food withstand forces encountered during
withstand forces encountered during and Drug Administration, 5630 Fishers use.
use. Lane, rm. 1061, Rockville, MD 20852,
Dated: June 16, 2015.
Section 510(m) of the FD&C Act and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday Leslie Kux,
provides that FDA may exempt a class
through Friday, and are available Associate Commissioner for Policy.
II device from the premarket notification
electronically at http:// [FR Doc. 2015–15328 Filed 6–22–15; 8:45 am]
requirements under section 510(k) of the
FD&C Act, if FDA determines that www.regulations.gov. BILLING CODE 4164–01–P

premarket notification is not necessary 1. DEN130047: De Novo Request per
to provide reasonable assurance of the 513(f)(2) from Auris Medtech Europe Ltd.,
safety and effectiveness of the device. dated November 21, 2013. DEPARTMENT OF HOMELAND
For this type of device, FDA has 2. Amendment to De Novo Request from SECURITY
determined that premarket notification Auris Medtech Europe Ltd., dated June 17,
2014. Coast Guard
is necessary to provide reasonable
assurance of the safety and effectiveness List of Subjects in 21 CFR Part 876
of the device. Therefore, this device 33 CFR Part 100
Medical devices.
type is not exempt from premarket Therefore, under the Federal Food, [Docket No. USCG–2013–0103]
notification requirements. Persons who Drug, and Cosmetic Act and under RIN 1625–AA08
intend to market this type of device authority delegated to the Commissioner
must submit to FDA a premarket of Food and Drugs, 21 CFR part 876 is Regattas and Marine Parades; Great
notification, prior to marketing the amended as follows: Lakes Annual Marine Events
device, which contains information
about the vibrator for climax control of PART 876—GASTROENTEROLOGY– AGENCY: Coast Guard, DHS.
premature ejaculation they intend to UROLOGY DEVICES ACTION: Notice of enforcement of
market. regulation.
■ 1. The authority citation for 21 CFR
II. Environmental Impact part 876 continues to read as follows: SUMMARY: The Coast Guard will enforce
The Agency has determined under 21 Authority: 21 U.S.C. 351, 360, 360c, 360e,
various special local regulations for
CFR 25.34(b) that this action is of a type 360j, 360l, 371. annual regattas and marine parades in
that does not individually or ■ 2. Republish § 876.5025 to read as the Captain of the Port Detroit zone from
cumulatively have a significant effect on follows: 9 a.m. on June 26, 2015 through 7 p.m.
the human environment. Therefore, on August 23, 2015. Enforcement of
neither an environmental assessment § 876.5025 Vibrator for climax control of these regulations is necessary and
mstockstill on DSK4VPTVN1PROD with RULES

nor an environmental impact statement premature ejaculation. intended to ensure safety of life on the
is required. (a) Identification. A vibrator for navigable waters immediately prior to,
climax control of premature ejaculation during, and immediately after these
III. Paperwork Reduction Act of 1995 is used for males who suffer from regattas or marine parades. During the
This final order establishes special premature ejaculation. It is designed to aforementioned period, the Coast Guard
controls that refer to previously increase the time between arousal and will enforce restrictions upon, and
approved collections of information ejaculation using the stimulating control movement of, vessels in a

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Document Created: 2018-02-22 11:15:32
Document Modified: 2018-02-22 11:15:32

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final order; republication.
Dates		This order is effective June 23, 2015. The classification was applicable on March 20, 2015.
Contact		Tuan Nguyen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G118, Silver Spring, MD 20993-0002, 301-796-5174, [email protected]
FR Citation		80 FR 35842

80 FR 35842 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation; Republication

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 120 (June 23, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration