80 FR 30353 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 102 (May 28, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 102 (May 28, 2015)
| Page Range | 30353-30355 | |
| FR Document | 2015-12852 |
[Federal Register Volume 80, Number 102 (Thursday, May 28, 2015)] [Rules and Regulations] [Pages 30353-30355] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-12852] ======================================================================= ----------------------------------------------------------------------- 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 AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (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 May 28, 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 [[Page 30354]] 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), 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) 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, Ergon Medical, Ltd., submitted a request for classification of the ProlongTM under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1). 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. 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 Mechanical Safety Testing. Failure. Labeling. Interference With Other Devices/Electrical Electromagnetic Equipment. Compatibility 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. [[Page 30355]] IV. Reference The following reference has 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 is available electronically at http://www.regulations.gov. 1. DEN130047: De Novo Request per 513(f)(2) from Ergon Medical Ltd., dated November 21, 2013. 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. Add Sec. 876.5025 to subpart F 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: May 21, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-12852 Filed 5-27-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 102 / Thursday, May 28, 2015 / Rules and Regulations 30353
is one that explains: (1) Why the direct necessary, to select regulatory and reserving subpart 1216.2, consisting
final rule is inappropriate, including approaches that maximize net benefits of §§ 1216.200 through 1216.205.
challenges to the rule’s underlying (including potential economic, Cheryl E. Parker,
premise or approach; or (2) why the environmental, public health and safety
direct final rule will be ineffective or NASA Federal Register Liaison Officer.
effects, distributive impacts, and
unacceptable without a change. In [FR Doc. 2015–12914 Filed 5–27–15; 8:45 am]
equity). E.O. 13563 emphasizes the
determining whether a comment importance of quantifying both costs BILLING CODE 7510–13–P
necessitates withdrawal of this direct and benefits of reducing costs,
final rule, NASA will consider whether harmonizing rules, and promoting
it warrants a substantive response in a flexibility. This rule has been DEPARTMENT OF HEALTH AND
notice and comment process. designated as ‘‘not significant’’ under HUMAN SERVICES
Background section 3(f) of E.O. 12866. Food and Drug Administration
On January 18, 2011, President Review Under the Regulatory Flexibility
Obama signed E.O. 13563, Improving Act 21 CFR Part 876
Regulations and Regulatory Review,
[Docket No. FDA–2015–N–1297]
directing agencies to develop a plan for The Regulatory Flexibility Act (5
a retrospective analysis of existing U.S.C. 601 et seq.) requires an agency to Medical Devices; Gastroenterology-
regulations. NASA developed its plan prepare an initial regulatory flexibility Urology Devices; Classification of the
and published it on the Agency’s open analysis to be published at the time the Vibrator for Climax Control of
Government Web site at http:// proposed rule is published. This Premature Ejaculation
www.nasa.gov/open/. The Agency requirement does not apply if the
conducted an analysis of its existing agency ‘‘certifies that the rule will not, AGENCY: Food and Drug Administration,
regulations to comply with the Order if promulgated, have a significant HHS.
and determined that subpart 1216.2, economic impact on a substantial ACTION: Final order.
Floodplain and Wetlands Management, number of small entities’’ (5 U.S.C. 603).
should be repealed. SUMMARY: The Food and Drug
This rule removes two subparts from
Subpart 1216.2 was promulgated Administration (FDA) is classifying the
Title 14 of the CFR that are already
January 4, 1979, [44 FR 1089] in vibrator for climax control of premature
reflected in existing NASA internal ejaculation into class II (special
response to Executive Order (E.O.) requirements and, therefore, does not
11988, Floodplain Management, and controls). The special controls that will
have a significant economic impact on apply to the device are identified in this
E.O. 11990, Protection of Wetlands.
a substantial number of small entities. order and will be part of the codified
Neither E.O. mandates that these
requirements be codified in the CFR. Review Under the Paperwork Reduction language for the classification of the
For example, E.O. 11988 subsection 2(d) Act vibrator for climax control of premature
states in pertinent part ‘‘. . . each ejaculation. The Agency is classifying
agency shall issue or amend existing This direct final rule does not contain the device into class II (special controls)
regulations and procedures . . .;’’ and any information collection requirements in order to provide a reasonable
E.O. 11990 section 6 states in pertinent subject to the Paperwork Reduction Act assurance of safety and effectiveness of
part ‘‘. . . agencies shall issue or amend of 1995 (44 U.S.C. 3501 et seq.). the device.
their existing procedures . . .’’ DATES: This order is effective May 28,
Review Under E.O. 13132
Therefore, this subpart will be repealed 2015. The classification was applicable
because it is now captured in NASA E.O. 13132, ‘‘Federalism,’’ 64 FR on March 20, 2015.
Interim Directive (NID) 8500.100, 43255 (August 4, 1999) requires FOR FURTHER INFORMATION CONTACT:
Floodplain and Wetlands Management. regulations be reviewed for Federalism Tuan Nguyen, Center for Devices and
NID 8500.100 is accessible at http:// effects on the institutional interest of Radiological Health, Food and Drug
nodis3.gsfc.nasa.gov/OPD_docs/NID_ states and local governments, and if the Administration, 10903 New Hampshire
8500_100_.pdf. Ave., Bldg. 66, Rm. G118, Silver Spring,
effects are sufficiently substantial,
Statutory Authority preparation of the Federal assessment is MD 20993–0002, 301–796–5174,
required to assist senior policy makers. tuan.nguyen@fda.hhs.gov.
The National Aeronautics and Space
The amendments will not have any SUPPLEMENTARY INFORMATION:
Act (the Space Act), 51 U.S.C. 20113 (a),
authorizes the Administrator of NASA substantial direct effects on state and I. Background
to make, promulgate, issue, rescind, and local governments within the meaning
of the E.O. Therefore, no Federalism In accordance with section 513(f)(1) of
amend rules and regulations governing the Federal Food, Drug, and Cosmetic
the manner of its operations and the assessment is required.
Act (the FD&C Act) (21 U.S.C.
exercise of the powers vested in it by List of Subjects in 14 CFR Part 1216 360c(f)(1)), devices that were not in
law. commercial distribution before May 28,
Regulatory Analysis Flood plains. 1976 (the date of enactment of the
Medical Device Amendments of 1976),
Executive Order 12866, Regulatory PART 1216—ENVIRONMENTAL generally referred to as postamendments
wreier-aviles on DSK5TPTVN1PROD with RULES
Planning and Review and Executive POLICY devices, are classified automatically by
Order 13563, Improvement Regulation statute into class III without any FDA
and Regulation Review ■ Accordingly, under the authority of rulemaking process. These devices
Executive Orders 13563 and 12866 the National Aeronautics and Space Act, remain in class III and require
direct agencies to assess all costs and as amended (51 U.S.C. 20113), NASA premarket approval, unless and until
benefits of available regulatory amends 14 CFR part 1216 by removing the device is classified or reclassified
alternatives and, if regulation is into class I or II, or FDA issues an order
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IV. Reference DEPARTMENT OF DEFENSE understanding of procedures with the
carriers.
The following reference has been Office of the Secretary The United States Transportation
placed on display in the Division of Command (USTRANSCOM) negotiates
Dockets Management (HFA–305), Food 32 CFR Part 243 and structures award of aircraft service
and Drug Administration, 5630 Fishers contracts with certificated civilian air
Lane, Rm. 1061, Rockville, MD 20852, [Docket ID: DOD–2013–OS–0130]
carriers willing to participate in the
and may be seen by interested persons RIN 0790–AJ08 CRAF program in order to ensure that a
between 9 a.m. and 4 p.m., Monday mobilization base of aircraft is capable
through Friday, and is available Ratemaking Procedures for Civil of responding to any level of defense-
electronically at http:// Reserve Air Fleet Contracts orientated situations.
www.regulations.gov. The ability to set rates maintains the
AGENCY: USTRANSCOM, DoD.
1. DEN130047: De Novo Request per 513(f)(2) CRAF program’s great flexibility to have
ACTION: Final rule.
from Ergon Medical Ltd., dated any air carrier in the program able to
November 21, 2013. SUMMARY: Section 366 of the National provide aircraft within 24 hours of
Defense Authorization Act for Fiscal activation to fly personnel and cargo to
List of Subjects in 21 CFR Part 876 Year 2012 directs the Secretary of any location in the world at a set rate
Medical devices. Defense to determine a fair and per passenger or ton mile, regardless of
reasonable rate of payment for airlift where the air carrier normally operates.
Therefore, under the Federal Food, It also provides the Secretary of Defense
services provided to the Department of
Drug, and Cosmetic Act and under the ability to respond rapidly to assist
Defense by air carriers who are
authority delegated to the Commissioner in emergencies and approved
participants in the Civil Reserve Air
of Food and Drugs, 21 CFR part 876 is humanitarian operations, both in the
Fleet Program. The Department of
amended as follows: United States and overseas where delay
Defense (the Department or DoD) is
promulgating regulations to establish could result in more than monetary
PART 876—GASTROENTEROLOGY— losses. The Government-set rate allows
UROLOGY DEVICES ratemaking procedures for civil reserve
air fleet contracts as required by Section contracts to any location, sometimes
366(a) in order to determine a fair and awarded within less than an hour, and
■ 1. The authority citation for 21 CFR
reasonable rate of payment. provides substantial commercial
part 876 continues to read as follows: capability on short notice.
DATES: This final rule is effective on
Authority: 21 U.S.C. 351, 360, 360c, 360e, During the initial CRAF program
360j, 360l, 371. June 29, 2015. years (between 1955 and 1962),
FOR FURTHER INFORMATION CONTACT: Mr. ratemaking to price DoD airlift service
■ 2. Add § 876.5025 to subpart F to read Richard Gates, Chief, Acquisition Law, relied upon price competition to meet
as follows: USTRANSCOM/TCJA, (618) 220–3982 its commercial airlift needs. This
§ 876.5025 Vibrator for climax control of
or Mr. Jeff Beyer, Chief, Business procurement method resulted in
premature ejaculation. Support and Policy Division, predatory pricing issues and failed to
USTRANSCOM/TCAQ, (618) 220–7021. provide service meeting safety and
(a) Identification. A vibrator for
SUPPLEMENTARY INFORMATION: performance requirements.
climax control of premature ejaculation
Congressional Subcommittee hearings
is used for males who suffer from Background
held at the time determined price
premature ejaculation. It is designed to The Civil Reserve Air Fleet (CRAF) is competition to be non-compensatory
increase the time between arousal and a wartime readiness program, based on and destructive to the industry. As a
ejaculation using the stimulating the Defense Production Act of 1950, as result, the ratemaking process was
vibratory effects of the device on the amended, (50 U.S.C. App. 2601 et seq.), implemented under the regulatory
penis. and Executive Order 13603 (National authority of the Civil Aeronautics Board
(b) Classification. Class II (special Defense Resource Preparedness), March (CAB). Ratemaking continued under the
controls). The special controls for this 16, 2012, to ensure quantifiable, CAB until deregulation in 1980. At that
device are: accessible, and reliable commercial time, civil air carriers and DoD’s
(1) The labeling must include specific airlift capability to augment DoD airlift contracting agency for long-term
instructions regarding the proper and to assure a mobilization base of international airlift, the Military Airlift
placement and use of the device. aircraft available to the Department of Command (MAC), agreed by a
(2) The portions of the device that Defense for use in the event of any level memorandum of understanding (MOU)
contact the patient must be of national emergency or defense- that CAB methodologies by which rates
demonstrated to be biocompatible. orientated situations. As a readiness for DoD airlift were established
(3) Appropriate analysis/testing must program, CRAF quantifies the number of produced fair and reasonable rates and
demonstrate electromagnetic passenger and cargo commercial assets furthered the objectives of the CRAF
compatibility safety, electrical safety, required to support various levels of program; and therefore, the parties
and thermal safety of the device. wartime requirements and thus allows agreed to continue to use CAB
(4) Mechanical safety testing must DoD to account for their use when methodologies for establishing MAC
demonstrate that the device will developing and executing contingency uniform negotiated rates under an MOU
operations and war plans. In addition, renewed every five years. MAC became
wreier-aviles on DSK5TPTVN1PROD with RULES
withstand forces encountered during
use. the CRAF program identifies how DoD Air Mobility Command (AMC) on June
gains access to these commercial assets 1, 1992. Ratemaking continued under
Dated: May 21, 2015. for operations by defining the AMC until January 1, 2007, when DoD’s
Leslie Kux, authorities and procedures for CRAF contracting authority for long-term
Associate Commissioner for Policy. activation. Finally, the program helps international airlift was transferred from
[FR Doc. 2015–12852 Filed 5–27–15; 8:45 am] ensure that the DoD has reliable lines of AMC to USTRANSCOM. On December
BILLING CODE 4164–01–P communication and a common 31, 2011, the National Defense
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Document Created: 2018-02-21 10:33:42
Document Modified: 2018-02-21 10:33:42
| 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. | |
| Dates | This order is effective May 28, 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 30353 |
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