[Federal Register: March 17, 2004 (Volume 69, Number 52)]
[Proposed Rules]
[Page 12598-12601]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17mr04-23]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. 1998N-1111]


Gastroenterology-Urology Devices; Classification for 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 external penile rigidity devices intended to create or
maintain sufficient penile rigidity for sexual intercourse into class
II (special controls). Also, FDA is giving notice of its intent to
exempt this type of device from the premarket notification (510(k))
requirements of the Federal Food, Drug, and Cosmetic Act. After
considering public comments on the proposed classification, FDA will
publish a final regulation classifying these devices. This action is
being taken to establish sufficient regulatory controls that will
provide reasonable assurance of the safety and effectiveness of this
device. Elsewhere in this issue of the Federal Register, FDA is
publishing a notice announcing the availability of a draft guidance
document that would serve as the special control for the devices if
this proposal becomes final.

DATES: Submit written or electronic comments by June 15, 2004. See
section IX of this document for the proposed effective date of a final
rule based on this document.

ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Room 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.


FOR FURTHER INFORMATION CONTACT: Janine Morris, 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

A. Regulatory Authorities

    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) (Public Law 94-295), the Safe Medical Devices Act of 1990
(SMDA) (Public Law 101-629), the Food and Drug Administration
Modernization Act (FDAMA) (Public Law 105-115), and the Medical Devices
User Fee and Modernization Act (MDUFMA) (Public Law 107-250)
established a comprehensive system for regulating medical devices
intended for human 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 section 513 of the act, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the
amendments), generally referred to as preamendments devices, are
classified after FDA has taken the following steps: (1) Received a
recommendation from a device classification panel (an FDA advisory
committee); (2) published the panel's recommendation for comment, along
with a proposed regulation classifying the device; and (3) published a
final regulation classifying the device. FDA has classified most
preamendments devices under these procedures.
    Devices that were not in commercial distribution before May 28,
1976, generally referred to as postamendments 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 until FDA performs the following tasks:
(1) Reclassifies the device into class I or II; (2) issues an order
classifying the device into class I or II in accordance with new
section 513(f)(2) of the act, as amended by the FDAMA; or (3) issues an
order finding the device to be substantially equivalent, in accordance
with section 513(i) of the act, to a legally marketed device that does
not require premarket approval. The agency determines whether new
devices are substantially equivalent to previously marketed 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 preamendments device that has been classified into class III may
be marketed, by means of premarket notification procedures, without
submission of a premarket approval application (PMA) until FDA issues a
final regulation under section 515(b) of the act (21 U.S.C. 360e(b))
requiring premarket approval.
    FDAMA added a new section 510(m) to the act (21 U.S.C. 360(m)). New
section 510(m) of the act provides that FDA may exempt a class II
device from the premarket notification requirements under section
510(k) of the act, if the agency determines that premarket notification
is not necessary to assure the safety and effectiveness of the device.
FDA has determined that premarket notification is not necessary to
assure the safety and effectiveness of external penile rigidity
devices.

B. Regulatory History

    External penile rigidity devices are preamendments devices. These
devices were not classified with the gastroenterology and urology
devices that were classified in 1983. FDA has reviewed marketing
submissions for these devices through the 510(k) process. Based on the
premarket notifications (510(k)) reviews, the agency believes that the
labeling of these devices adequately informs users and practitioners
about the safe and effective use of the devices.
    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 devices. During a
public meeting on August 7, 1997, the Panel discussed the history,
composition, and usage of external penile rigidity devices. The Panel
recommended classifying

[[Page 12599]]

external penile rigidity devices into class II with labeling
recommendations as special controls (Ref. 1).
    In the Federal Register of January 4, 1999 (64 FR 62), FDA issued a
proposed rule to classify external penile rigidity devices into class
II. The January 4, 1999, proposal provided the regulatory history of
external penile rigidity devices as well as the recommendation of the
Panel that these devices be classified into class II (special
controls). Specifically, the Panel recommended that FDA classify the
devices into class II because it concluded that special controls, in
addition to general controls, would provide reasonable assurance of the
safety and effectiveness of the devices, and that there was sufficient
information to establish special controls to provide that assurance.
FDA agreed with the Panel's recommended classification.
    The January 4, 1999, proposed rule provided an opportunity for
interested persons to submit comments. The 90-day comment period ended
on April 15, 1999. FDA received no comments.
    FDA has decided to repropose the classification of this device to
modify the description of external penile rigidity devices to clarify
its intended use. In addition, FDA, on its own initiative, is proposing
to exempt these devices from premarket notification requirements. The
agency believes that premarket notification is not necessary to assure
the safety and effectiveness of the device for the following reasons:
(1) FDA received no adverse event reports regarding the use of external
penile rigidity devices from 1997 to the present and (2) FDA conducted
a scientific literature review from 1996 to June 2003, which continued
to show that the devices are safe and effective when used properly. FDA
also believes that a special controls guidance document with labeling
recommendations addressing proper usage, along with the general
controls, would provide reasonable assurance of the safety and
effectiveness of the devices.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in a
guidance document the agency issued on February 19, 1998, entitled
``Procedures for Class II Device Exemptions From Premarket
Notification, Guidance for Industry and CDRH Staff.'' You may obtain
that guidance through the Internet on FDA's Center for Devices and
Radiological Health (CDRH) home page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh or by

fax through CDRH Facts-on-Demand at 1-800-899-0381 or 301-827-0111.
Specify ``159'' when prompted for the document shelf number.

III. Recommendation of the Panel

A. Device Identification

    The Panel made the following device identification recommendation:
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 unanimously recommended that FDA classify external penile
rigidity devices into class II (special controls). The Panel believed
that special controls regarding labeling recommendations would provide
reasonable assurance of the safety and effectiveness of the device
type. The Panel advised that the labeling provide the following
information: (1) The identified risks to health of this device type;
(2) relevant contraindications, warnings, and precautions; (3) possible
methods of resolution of the problems/risks associated with the use of
the devices; and (4) device-specific information. Device-specific
information (64 FR 62) contains warnings and precautions, including,
but not limited to, the following:
1. Information Relevant to Vacuum Pumps
    The user should apply the minimum amount of vacuum pressure
necessary to achieve an erection. Misuse of a vacuum pump may aggravate
already existing medical conditions such as Peyronie's disease,
priaprism, and urethral strictures.
2. Information Relevant to Constriction Rings
    The user should restrict use of the device to 30 minutes and should
not fall asleep wearing the constriction ring. Prolonged use of the
constriction ring without removal may cause permanent injury to the
penis.
    Frequent use of constrictions rings may result in bruising at the
base of the penis. The user should not use constrictions rings if there
is decreased ability to sense pain in the penis, because pain may occur
as a warning sign that the device may be causing injury.
3. Information Relevant to Penile Splints
    The user should consult a physician if any injuries occur to either
the user or the user's partner.

C. Summary of Reasons for Recommendation

    The Panel recommended that external penile rigidity devices be
classified into class II. The Panel believed that special controls
regarding labeling recommendations, in addition to general controls,
would provide reasonable assurance of the safety and effectiveness of
the devices, and that 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 the Panel members' knowledge
and clinical experience, as well as published literature on external
penile rigidity devices (Refs. 2 through 4).

E. Risks to Health

    The Panel identified pain and/or discomfort, bruising, hemorrhage
and/or hematoma formation, penile injury and penile gangrene (if blood
flow is restricted too long) as risks and possible side effects
associated with the use of these external penile rigidity devices.
After considering the Panel's deliberations, as well as the published
literature and medical device reports, FDA evaluated the risks to
health associated with the use of external penile rigidity devices. FDA
categorized the following as risks to health: (1) Tissue injury or
trauma; (2) aggravation of existing medical conditions, such as
Peyronie's disease, priaprism, and urethral strictures; and (3)
infection/adverse tissue reactions.
1. Tissue Injury or Trauma
    Tissue injury and trauma are risks to health associated with the
use of external penile rigidity devices. Prolonged use of constriction
bands over 30 minutes without removal may cause permanent injury to the
penis because of restricted blood flow. Frequent use of constriction
rings also may result in bruising at the base of the penis. Misuse 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 hematoma formation.
Misuse of a penile splint may cause vaginal trauma to the user's
partner.

[[Page 12600]]

2. Aggravation of Certain Existing Medical Conditions
    Misuse of a vacuum pump or constriction ring may aggravate already
existing medical conditions, such as Peyronie's disease, priaprism, and
urethral strictures. Peyronie's disease involves the formation of
hardened tissue in the penis that causes pain, curvature, and
distortion, usually during erection. Priaprism is the persistent,
usually painful erection of the penis as a consequence of disease. A
urethral stricture is an area of hardened tissue which narrows the
urethra and may cause pain and difficulty in urination. Increased
pressure from a vacuum pump or constriction ring may exacerbate the
symptoms of these medical conditions.
3. Infection/Adverse Tissue Reactions
    The materials used in external penile rigidity devices may present
a risk to health when in contact with skin by causing adverse tissue
reactions with respect to cytotoxicity, sensitization, or irritation.
Infection is also a potential risk as a result of injury or inadequate
cleaning of the devices.

F. Special Control

    FDA believes that FDA's guidance document entitled ``Class II
Special Controls Guidance Document: External Penile Rigidity Devices;
Guidance for Industry and FDA Staff'' can provide reasonable assurance
of the safety and effectiveness of external penile rigidity devices.
FDA agrees with the Panel that specific labeling recommendations and
adequate instructions for users are appropriate special controls. FDA
believes that guidance on device design, in combination with labeling
instructions, will also help assure a reasonable assurance of safety
and effectiveness.
    The guidance document addresses Panel and agency concerns about
tissue injury and trauma, aggravation of existing medical conditions
such as Peyronie's disease, priaprism, and urethral strictures, and
infection/adverse tissue reactions.
1. Tissue Injury and Trauma
    a. Labeling. The section addressing general labeling provisions for
external penile rigidity devices will help minimize tissue injury and
trauma due to user misuse by providing comprehensive instructions for
use in language written and formatted for the lay person. The
instructions should provide the following information: (1) How to size,
place, operate, and remove the device, (2) potential risks and hazards
associated with using the device, and (3) warning statements and
consequences that emphasize their importance.
    b. Design features. The section on design features has specific
safety-related recommendations for constriction rings, vacuum pumps,
and penile splints to reduce user and partner injury. The guidance
document addresses manual safety release mechanisms and shape and
surface designs that do not promote extended continuous use.
2. Aggravation of Certain Existing Medical Conditions
    The use of vacuum pumps or constriction rings may aggravate certain
existing medical conditions such as Peyronie's disease, priaprism, or
urethral strictures. The guidance document recommends additional
labeling precautions specific to vacuum pumps and constriction rings to
minimize the risk to users with the previously mentioned medical
conditions.
3. Infection/Adverse Tissue Reactions
    a. Labeling. The labeling recommendations for reducing tissue
injury or trauma also will help reduce the risk of infection as a
result of tissue injury. The section on general labeling of external
penile rigidity devices provides for manufacturers to include
instructions for cleaning the devices to minimize the risk of infection
from contaminated sources.
    b. Design features. The section on design features contains
recommendations for conformance to international standards for
materials used in constriction rings, vacuum pumps, and penile splints
to avoid adverse tissue reactions regarding cytotoxicity,
sensitization, and irritation. Design features include recommendations
for device shape and surface design as well as safety to minimize the
risk of injury and the potential risk of infection to injured tissue.

IV. Proposed Classification

    FDA agrees with the Panel's recommendation to classify these
devices into class II (special controls). FDA believes that classifying
external penile rigidity devices into class II is appropriate because
special controls, in addition to general controls, would provide
reasonable assurance of the safety and effectiveness of these devices,
and there is sufficient information to establish special controls to
provide this assurance.
    Additionally, the agency believes that premarket notification is
not necessary to assure the safety and effectiveness of the device for
the following reasons: (1) FDA received no adverse event reports
regarding the use of external penile rigidity devices from 1997 to the
present and (2) FDA conducted a scientific literature review from 1996
to June 2003, which continued to show that the devices are safe and
effective when used properly. Serious complications are rare. FDA also
believes that a special controls guidance document with labeling
recommendations addressing proper usage, along with the general
controls, would provide reasonable assurance of the safety and
effectiveness of the devices. In this proposal, the agency is giving
notice of its intent to exempt the devices from premarket notification
requirements.
    FDA believes that the device description recommended by the Panel
in 1997 should reflect more accurately the intended use of the devices.
FDA proposes that the device identification read as follows: External
penile rigidity devices are devices intended to create or maintain
sufficient penile rigidity for sexual intercourse. External penile
rigidity devices include vacuum pumps, constriction rings, and penile
splints, which are mechanical, powered, or pneumatic devices.

V. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this proposed
classification 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.

VI. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Public Law 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 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.

[[Page 12601]]

    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. This proposed rule will relieve a burden and
simplify the marketing of these devices by exempting the devices from
premarket notification requirements. The guidance document is based on
existing review practices and will not impose new burdens on
manufacturers of these devices. The agency, therefore, certifies that
the proposed rule will not have a significant economic impact on a
substantial number of small entities. Therefore, under the Regulatory
Flexibility Act, no further analysis is required.

VII. Submission of Comments

    You may submit written or electronic comments regarding this
proposal to the Division of Dockets Management (see ADDRESSES). Submit
a single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. You should
identify comments with the docket number found in brackets in the
heading of this document. Any comments FDA receives will be available
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

VIII. Paperwork Reduction Act of 1995

    FDA concludes that this proposed rule contains no collection of
information that is subject to review by the Office of Management and
Budget under the Paperwork Reduction Act of 1995.

IX. Proposed Effective Date

    FDA is proposing that any final rule based on this proposal become
effective 30 days after the date of its publication in the Federal
Register.

X. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 am. and 4 pm., Monday through 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.

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, FDA proposes
that 21 CFR part 876 be amended to read 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 876.1 is amended by adding paragraph (e) to read as
follows:


Sec.  876.1  Scope.

* * * * *
    (e) Guidance documents referenced in this part are available on the
Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html.

    3. Section 876.5020 is added to subpart F to read as follows:


Sec.  876.5020  External penile rigidity devices.

    (a) Identification. External penile rigidity devices are devices
intended to create or maintain sufficient penile rigidity for sexual
intercourse. External penile rigidity devices include vacuum pumps,
constriction rings, and penile splints which are mechanical, powered,
or pneumatic devices.
    (b) Classification. Class II (special controls). The devices are
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec.  876.9. The
special control for these devices is the FDA guidance document entitled
``Class II Special Controls Guidance Document: External Penile Rigidity
Devices; Draft Guidance for Industry and FDA.'' See Sec.  876.1(e) for
the availability of this guidance document.

    Dated: March 4, 2004.
Beverly Chernaik Rothstein,
Acting Deputy Director for Policy and Regulations, Center for Devices
and Radiological Health.
[FR Doc. 04-5983 Filed 3-16-04; 8:45 am]

BILLING CODE 4160-01-S