External Penile Rigidity Devices; Proposed Classification for the External Penile Rigidity Devices

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.

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

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

[[Page 64]]

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

[[Page 65]]

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