[Federal Register Volume 64, Number 1 (Monday, January 4, 1999)]
[Proposed Rules]
[Pages 62-65]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-34733]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. 98N-1111]
External Penile Rigidity Devices; Proposed Classification for the
External Penile Rigidity Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to
classify the generic type of external penile rigidity device including
constriction rings, vacuum pumps, and penile splints for the management
of erectile dysfunction. These devices fit on, over, or around the
penis to support, promote, or maintain sufficient penile rigidity for
sexual intercourse. Under the proposal, the external penile rigidity
devices would be classified into class II (special controls). The
agency is issuing in this document the recommendations of the
Gastroenterology-Urology Advisory Panel regarding the classification of
these devices. After considering public comments on the proposed
classification, FDA will publish a final regulation classifying this
device. This action is being taken to establish sufficient regulatory
controls that will provide reasonable assurance of the safety and
effectiveness of this device.
DATES: Written comments by April 5, 1999. See section V of this
document for the proposed effective date of a final rule based on this
document.
ADDRESSES: Submit written comments to the Documents Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Donald St. Pierre, Center for Devices
and Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2194.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et. seq.), as amended by the Medical Device Amendments of 1976 (the
1976 amendments) (Pub. L. 94-295) and the Safe Medical Devices Act of
1990 (the SMDA) (Pub. L. 101-629), established a comprehensive system
for the regulation of medical devices intended for human
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use. Section 513 of the act (21 U.S.C. 360c) established three
categories (classes) of devices, depending on the regulatory controls
needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
Under the 1976 amendments, class II devices were defined as those
devices for which there is insufficient information to show that
general controls themselves will assure safety and effectiveness, but
for which there is sufficient information to establish performance
standards to provide such assurance. The SMDA broadened the definition
of class II devices to mean those devices for which there is
insufficient information to show that general controls themselves will
assure safety and effectiveness, but for which there is sufficient
information to establish special controls to provide such assurance.
Special controls may include performance standards, postmarket
surveillance, patient registries, development and dissemination of
guidelines, recommendations, and any other appropriate actions the
agency deems necessary (section 513 (a)(1)(B) of the act).
Under section 513 of the act, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the 1976
amendments), generally referred to as preamendment devices, are
classified after FDA has met three requirements: (1) FDA has received a
recommendation from a device classification panel (an FDA advisory
committee); (2) FDA has published the panel's recommendation for
comment, along with a proposed regulation classifying the device; and
(3) FDA has published a final regulation classifying the device. FDA
has classified most preamendment devices under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976, generally referred to as postamendment devices, are classified
automatically by statute (section 513(f) of the act) into class III
without any FDA rulemaking process. Those devices remain in class III
and require premarket approval, unless and until FDA issues an order
finding the device to be substantially equivalent, under section 513(i)
of the act, to a predicate device that does not require premarket
approval. The agency determines whether new devices are substantially
equivalent to previously offered devices by means of premarket
notification procedures in section 510(k) of the act (21 U.S.C. 360(k))
and 21 CFR part 807 of the regulations.
A preamendment device that has been classified into class III may
be marketed, by means of premarket notification procedures, without
submission of a premarket approval application until FDA issues a final
regulation under section 515(b) of the act (21 U.S.C. 360e(b))
requiring premarket approval.
Consistent with the act and the regulations, FDA consulted with the
Gastroenterology-Urology Advisory Panel (the Panel), an FDA advisory
committee, regarding the classification of these external penile
rigidity devices. During a public meeting held Thursday, August 7,
1997, the Panel discussed the usage and history of external penile
rigidity devices, specifically constriction rings, vacuum pumps, and
penile splints used for the management of erectile dysfunction.
The panel discussed the usage and composition of each of these
devices. Constriction rings are devices that are placed around the base
of the erect penis for the duration of sexual intercourse to restrict
the flow of venous blood leaving the penis. Constriction rings are
usually elastic bands or adjustable loops, and they must be designed to
include handles or tabs so that they can be readily removed from the
penis.
Vacuum erection systems are devices consisting of vacuum pumps
(either hand-operated or motorized) and penile cylinders. They produce
an erection by creating a vacuum around the flaccid penis to induce
passive blood flow into the penis, thus producing an erection. Once a
satisfactory erection is obtained, the user often places a constriction
ring around the base of the erect penis, prior to removing the vacuum
cylinder, in order to maintain the erection.
Penile splints are rigid or flexible support structures that are
externally attached to or placed along the penis to physically support
the penis during sexual intercourse.
External penile rigidity devices are preamendment devices not
included as part of the gastroenterology and urology devices that were
classified in 1983. FDA has reviewed marketing applications for these
devices through the premarket notification or 510(k) process.
The premarket notifications or 510(k) reviews involved verifying
that the labeling of these devices adequately informs both patients and
practitioners on their safe use. Additionally, the premarket
notifications or 510(k) reviews ensure that the device has certain key
safety features, such as handles on constriction rings for quick
removal and safe limits on the maximum vacuum pressure that can be
generated.
Pain and/or discomfort, bruising, hemorrhage and/or hematoma
formation, penile injury, and penile gangrene (if blood flow is
restricted too long) are risks and possible side effects associated
with the use of these external penile rigidity devices.
Currently, these devices are offered both over the counter and by
prescription. While the over the counter and prescription devices are
similar, the differences distinguishing the over the counter and
prescription devices are in their labeling and packaging.
II. Recommendation of the Panel
During the public meeting held on Thursday, August 7, 1997, the
Panel made the following recommendation for the classification of
external penile rigidity devices into class II.
A. Identification
Penile rigidity devices are generic external devices that include
constriction rings, vacuum pumps, and penile splints for the management
of erectile dysfunction. These devices fit on, over, or around the
penis to support, promote, or maintain sufficient penile rigidity for
sexual intercourse.
B. Recommended Classification of the Panel
The Panel recommended that external penile rigidity devices be
classified into class II, special controls devices. Based on the
available information, the Panel believes that, in addition to general
controls, the following special controls regarding labeling
recommendations are necessary to provide reasonable assurance of the
safety and effectiveness of the external penile rigidity devices with
regard to the identified risks to health of this device:
1. Labeling for the external penile rigidity device should include
the device name, corporation name, address, telephone number, intended
use, disposable/single use status (if applicable), a description of the
device (including dimensional specifications), and directions for use;
2. The labeling should include the indications for use and
identification of the population(s) for whom the device is appropriate;
3. The directions for use should contain comprehensive instructions
on how to size, place, operate, remove, and clean the device;
4. The labeling should include the warning: ``If you cannot achieve
an erection that is sufficient for sexual intercourse, see your doctor
before using
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this device to be sure that it will not aggravate another medical
condition you might have. Also, your doctor will be able to check you
for some of the most common causes of erection problems, such as
diabetes, multiple sclerosis, cirrhosis of the liver, chronic kidney
failure, or alcoholism.''; and
5. Relevant contraindications, warnings, and precautions should be
included in the labeling of the device along with possible methods of
resolution of the problems/risks associated with the use of the device.
Specifically, we believe that the warning and cautionary statements
listed in section II.B.1.2.and 3 of this document by device type should
be addressed in the labeling for these devices using terminology well-
understood by the average layperson as follows:
1. Information Relevant to Constriction Rings
Use of the device should be restricted to 30 minutes. Do not fall
asleep wearing the constriction ring. Prolonged use of the constriction
bands (i.e., without removal) may cause permanent injury to the penis.
Consult your physician should any complications occur and
discontinue use of the device if such conditions persist.
The user should allow 60 minutes between uses.
Use the largest size constriction ring which maintains an erection.
Constriction rings should not be used under the influence of
alcohol or drugs.
Constriction rings are not intended for use as a contraceptive/
birth control.
Frequent use of constriction rings may result in bruising at the
base of the penis (where the shaft of the penis meets the pubic area).
Do not use the device if you have a decreased ability to sense pain
in the area of the penis because pain may occur as a warning sign that
the device may be causing injury.
Do not use the device if you have insufficient manual dexterity to
easily remove the device.
2. Information Relevant to Vacuum Pumps
Consult your physician should any complications occur and
discontinue use of the device if such conditions persist.
The user should apply the minimum amount of vacuum pressure
necessary to achieve an erection.
The user should stop using the vacuum pump if pain occurs.
Vacuum pumps should not be used under the influence of alcohol or
drugs.
Use of a vacuum pump may bruise or rupture the blood vessels either
immediately below the surface of the skin or within the deep structures
of the penis or scrotum, resulting in hemorrhage and/or the formation
of a hematoma.
Misuse of a vacuum pump may aggravate already existing medical
conditions such as Peyronie's disease, priapism, and urethral
strictures.
Misuse of the vacuum pump could result in swelling of the penis
and/or serious permanent injury to the penis.
Do not use an electrically powered vacuum pump in or near water.
Vacuum pumps should not be used by men who take anticoagulants
(blood thinners).
Vacuum pumps do not provide a satisfactory erection in every man.
If erection satisfactory for intercourse is not achieved the user
should consult with a physician familiar with such devices to determine
the cause.
Do not use the device if you have a decreased ability to sense pain
in the area of the penis, because pain may occur as a warning sign that
the device may be causing injury.
3. Information Relevant to Penile Splints
Consult a physician if any injuries occur to either yourself or
your sexual partner, and discontinue use of the device if such
conditions persist.
C. Summary of Reasons for Recommendation
The Panel believes the external penile rigidity devices should be
classified into class II because special controls, in addition to
general controls, would provide reasonable assurance of the safety and
effectiveness of the device, and there is sufficient information to
establish special controls to provide such assurance.
D. Summary of Data Upon Which the Recommendation is Based
The panel based its recommendation on their knowledge and
experience in addition to published literature on external penile
rigidity devices (Refs. 2 through 4).
E. Risks to Health
Pain and/or discomfort, bruising, hemorrhage and/or hematoma
formation, penile injury and penile gangrene (if blood flow is
restricted too long) are risks and possible side effects associated
with the use of these external penile rigidity devices. FDA believes,
however, that the special controls regarding labeling recommendations
will provide reasonable assurance of the safety and effectiveness of
the external penile rigidity devices.
III. Proposed Classification
FDA agrees with the Panel recommendation for classification of
these devices under class II. FDA believes the external penile rigidity
devices should be classified into class II because special controls, in
addition to general controls, would provide reasonable assurance of the
safety and effectiveness of the device, and there is sufficient
information to establish special controls to provide such assurance.
IV. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday though Friday.
1. Gastroenterology and Urology Devices Panel of the Medical
Devices Advisory Committee transcript, August 7, 1997.
2. Lewis, J. H. et al., ``A way to help your patients who use
vacuum devices,'' Contemporary Urology, vol. 3, No. 12: 15-24, 1991.
3. Montague, D. K. et al., ``Clinical Guidelines Panel on
Erectile Dysfunction; Summary Report on the Treatment of Erectile
Dysfunction,'' Journal of Urology, 156, 2007-2011, 1996.
4. ``NIH Consensus Statement-Impotence,'' National Institutes of
Health, vol. 10, No. 4, 1992.
V. Proposed Effective Date
The agency proposes that any final rule that may issue based on
this proposed rule become effective 30 days after its date of
publication in the Federal Register.
VI. Environmental Impact
The agency has determined under 21 CFR 25.24(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.
VII. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), as
amended by subtitle D of the Small Business Regulatory Fairness Act of
1996 (Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4). Executive Order 12866 directs agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
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net benefits (including potential economic, environmental, public
health and safety and other advantages, distributive impacts, and
equity). The agency believes that this proposed rule is consistent with
the regulatory philosophy and principles identified in the Executive
Order. In addition, the proposed rule is not a significant regulatory
action as defined by the Executive Order and so is not subject to
review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the proposed rule does not impose any new
requirements, it will impose no significant economic impact on any
small entities. The agency certifies that this proposed rule, if
issued, will not have a significant economic impact on a substantial
number of small entities. In addition, this proposed rule will not
impose costs of $100 million or more on either the private sector or
State, local, and tribal governments in the aggregate, and therefore a
summary statement or analysis under section 202(a) of the Unfunded
Mandates Reform Act of 1995 is not required.
VIII. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
IX. Submission of Comments
Interested persons may, on or before April 5, 1999, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted except
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday.
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, it is
proposed that 21 CFR part 876 be amended as follows:
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
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.
2. Section 876.5020 is added to subpart F to read as follows:
Sec. 876.5020 External penile rigidity devices.
(a) Identification. An external penile rigidity device is a device
intended to help manage erectile dysfunction. External penile rigidity
devices consist of vacuum pumps, constriction rings, and penile
splints. The vacuum pump has a cylinder that is placed over the penis
and produces an erection by creating a vacuum around the penis. The
constriction ring is placed around the base of the erect penis, keeping
the blood in the penis and thus, maintaining the erection. Penile
splints are rigid or flexible support structures that are externally
attached to the penis to physically support the penis during sexual
intercourse.
(b) Classification. Class II (special controls).
Dated: December 17, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-34733 Filed 12-31-98; 8:45 am]
BILLING CODE 4160-01-F