[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

[[Page 63]]

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