65770 Federal Register / Vol. 62, No. 241 / Tuesday, December 16, 1997 / Proposed Rules

Modification, OPT10 9205–57, Wing Rear

Attachment Bracket, dated April 1996; and

(ii) Incorporate wing rear attachment fitting

reinforcement kit No. OPT10 920300 in

accordance with the Technical Instruction of

Modification, OPT109203–57, Wing Rear

Attachment Bracket, dated April 1996.

(3) If any fitting is not found cracked, prior

to further flight, incorporate wing rear

attachment fitting reinforcement kit No.

OPT10 920300 in accordance with the

Technical Instruction of Modification,

OPT109203–57, Wing Rear Attachment

Bracket, dated April 1996.

(b) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

(c) An alternative method of compliance or

adjustment of the compliance time that

provides an equivalent level of safety may be

approved by the Manager, Small Airplane

Directorate, FAA, 1201 Walnut, suite 900,

Kansas City, Missouri 64106. The request

shall be forwarded through an appropriate

FAA Maintenance Inspector, who may add

comments and then send it to the Manager,

Small Airplane Directorate.

Note 4: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Small Airplane

Directorate.

(d) All persons affected by this directive

may obtain copies of the documents referred

to herein upon request to Socata—Groupe

Aerospatiale, Socata Product Support,

Aeroport Tarbes-Ossun-Lourdes, B P 930,

65009 Tarbes Cedex, France; or Perry

Airport, 7501 Pembroke Road, Pembroke

Pines, Florida 33023. These documents may

also be examined at the FAA, Central Region,

Office of the Regional Counsel, Room 1558,

601 E. 12th Street, Kansas City, Missouri

64106.

Note 5: The subject of this AD is addressed

in French AD 94–249(A)R1, dated June 19,

1996.

Issued in Kansas City, Missouri, on

December 10, 1997.

Michael Gallagher,

Manager, Small Airplane Directorate, Aircraft

Certification Service.

[FR Doc. 97–32727 Filed 12–15–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. 97N–0481]

Gastroenterology-Urology Devices:

Reclassification of the Penile Rigidity

Implant

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

reclassify the penile rigidity implant, a

medical device intended to provide

penile rigidity in men diagnosed as

having erectile dysfunction, from class

III to class II. The special controls

identified in this proposed rule are the

physician and patient labeling,

biocompatibility testing, mechanical

reliability performance testing, clinical

testing, and sterilization requirements

described in FDA’s guidance document

entitled ‘‘Guidance for the Content of

Premarket Notifications for Penile

Rigidity Implants.’’ This reclassification

is being proposed on the agency’s own

initiative based on new information.

This action is being taken under the

Federal Food, Drug, and Cosmetic Act

(the act), as amended by the Medical

Device Amendments of 1976 (the 1976

amendments) and the Safe Medical

Devices Act of 1990 (the SMDA).

DATES: Written comments by March 16,

1998. FDA proposes that any final

regulation based on this proposal

become effective 30 days after its date

of publication in the Federal Register.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: John

H. Baxley, Center for Devices and

Radiological Health (HFZ–470), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2194.

SUPPLEMENTARY INFORMATION:

I. Regulatory Authorities

The act, as amended by the 1976

amendments (Pub. L. 94–295) and the

SMDA (Pub. L. 101–629), established a

comprehensive system for the regulation

of 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: (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 prior to May 28, 1976,

generally referred to as post amendment

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 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. Section 515(b) of

the act describes a two step regulatory

process. A notice of proposed

rulemaking in the Federal Register,

which includes the proposed regulation,

proposed findings of risks and benefits

of the device, an opportunity for the

submission of comments and an

opportunity to request reclassification,

is followed by the final rule which

issues the regulation.

In 1990, the SMDA added section

515(i) to the act. This section requires

FDA to issue an order to manufacturers

of preamendment class III devices for

which no final regulation requiring the

submission of PMA’s has been issued to

submit to the agency a summary of, and

a citation to any information known or

otherwise available to them respecting

such devices, including adverse safety

and effectiveness information which has

not been submitted under section 519 of

the act (21 U.S.C. 360i). Section 519 of

the act requires manufacturers,

importers, distributors and device user

facilities to submit adverse event reports

of certain device-related events. Section

515(i) of the act also directs FDA to

either revise the classification of the

device into class I or class II or require

the device to remain in class III and

establish a schedule for the issuance of

a rule requiring the submission of

PMA’s for those devices remaining in

class III.
Federal Register / Vol. 62, No. 241 / Tuesday, December 16, 1997 / Proposed Rules 65771

In the Federal Register of May 6, 1994

(59 FR 23731), FDA announced its

strategy and made available a document

setting forth its strategy for

implementing the provisions of the

SMDA that require FDA to review the

classification of preamendment class III

devices. In accordance to this plan, the

agency divided preamendment class III

devices into the following three groups:

Group 1 devices are devices that FDA

believes raise significant questions of

safety and/or effectiveness, but are no

longer used or are in very limited use.

Group 2 devices are devices that FDA

believes have a high potential for being

reclassified into class II. Group 3

devices are devices that FDA believes

are currently in commercial distribution

and are not likely candidates for

reclassification. FDA also announced its

intent to call for submission of PMA’s

for the 15 highest priority devices in

Group 3, and for all Group 1 devices.

The agency also announced its intent to

issue an order under section 515(i) of

the act for the remaining Group 3

devices and for all of the Group 2

devices.

In the Federal Register of August 14,

1995 (60 FR 41984), FDA published two

orders for Certain Class III Devices;

requiring the submission of safety and

effectiveness information in accordance

with the Preamendments Class III

Strategy for implementing section 515(i)

of the act. Each of the orders described

in detail the format for submitting the

type of information required by section

515(i) of the act so that the information

submitted would clearly support

reclassification or indicate that a device

should be retained in class III. The

orders also scheduled the required

submissions in groups of nine devices at

6-month intervals beginning with

August 14, 1996. The device proposed

in this regulation for reclassification

was included in the August 14, 1995,

order on Group 2 devices (Docket No.

94N–0417).

Reclassification of classified

preamendments devices is governed by

section 513(e) of the act. This section

provides that FDA may, by rulemaking,

reclassify a device (in a proceeding that

parallels the initial classification

proceeding) based upon ‘‘new

information.’’ The reclassification can

be initiated by FDA or by the petition

of an interested person. The term ‘‘new

information,’’ as used in section 513(e)

of the act, includes information

developed as a result of a reevaluation

of the data before the agency when the

device was originally classified, as well

as information not presented, not

available, or not developed at that time.

(See, e.g., Holland Rantos v. United

States Department of Health, Education,

and Welfare, 587 F.2d 1173, 1174 n.1

(D.C. Cir. 1978); Upjohn v. Finch, 422

F.2d 944 (6th Cir. 1970); Bell v.

Goddard, 366 F.2d 177 (7th Cir. 1966).)

Reevaluation of the data previously

before the agency is an appropriate basis

for subsequent regulatory action where

the reevaluation is made in light of

changes in ‘‘medical science.’’ (See

Upjohn v. Finch, supra, 422 F.2d at

951.) However, regardless of whether

data before the agency are past or new

data, the ‘‘new information’’ on which

any reclassification is based is required

to consist of ‘‘valid scientific evidence’’

as defined in section 513(a)(3) of the act

and 21 CFR 860.7(c)(2). FDA relies upon

‘‘valid scientific evidence’’ in the

classification process to determine the

level of regulation for devices. For the

purpose of reclassification, the valid

scientific evidence upon which the

agency relies must be publicly available.

Publicly available information excludes

trade secret and/or confidential

commercial information, e.g., the

contents of PMA’s. (See section 520(c)

of the act (21 U.S.C. 360j(c)).)

II. Regulatory History of the Device

In the Federal Register of November

23, 1983 (48 FR 53012 at 53023), FDA

issued a final rule classifying the penile

rigidity implant into class III (21 CFR

876.3630). The preamble to the proposal

to classify the device (46 FR 7578,

January 23, 1981) included the

recommendations of the

Gastroenterology and Urology Devices

Advisory Panel and the General and

Plastic Surgery Devices Advisory Panel

(the Panels), FDA advisory committees,

which met regarding the classification

of the device. The Panels both

recommended that the device be

classified in class II, listing poor tissue

compatibility, tissue trauma, and device

structural problems as potential risks of

the device and citing that general

controls and performance standards

would provide reasonable assurance of

the safety and effectiveness of the

device.

FDA disagreed with the Panels’

recommendations and proposed that the

penile rigidity implant be classified into

class III. The proposal stated that the

agency believed that insufficient

information existed to determine that

general controls would provide

reasonable assurance of safety and

effectiveness of the device, or to

establish a performance standard to

provide this assurance. The proposal

stated that premarket approval is

necessary for this device because it

presents a potential unreasonable risk of

injury due to: (1) Adverse tissue

reaction if the materials used in the

construction of the device are not

biocompatible; (2) infection resulting

from defects in the design, construction,

packaging, or processing of the device;

(3) urinary retention if the prosthesis

compresses the urethra; and (4) erosion

or malfunction if the implant is

improperly sized or mechanically

breaks. In support of its proposal to

strengthen regulatory surveillance of the

device, FDA cited references supporting

the proposed classification.

In the Federal Register of April 7,

1981 (46 FR 20687), FDA reopened the

comment period for the proposed

regulation classifying this device for an

additional 60 days. This addition 60-day

comment period was established

because the proposed classification

regulation for the penile rigidity implant

stated incorrectly that the

Gastroenterology and Urology Devices

Advisory Panel recommended that the

device be classified into class III, rather

than class II. In the April 7, 1981 notice,

FDA announced that on April 13, 1981,

a meeting of the Panel would be held.

During this meeting, the Panel reviewed

all comments, and again recommended

that the penile rigidity implant be

classified into class II. No other

comments were received during the

remainder of the comment period.

Again, FDA disagreed with the Panel’s

recommendation and proposed that the

penile rigidity implant be classified into

class III. FDA searched the published

literature and further documented the

potential risks to health resulting from

silicone implants, such as silicone

particle migration and allergic or

adverse tissue reaction.

The preamble to the November 23,

1983 (48 FR 53012), final rule

classifying the device into class III

advised that the earliest date by which

PMA’s for the device could be required

was June 30, 1986, or 90 days after

issuance of a rule requiring premarket

approval for the device, whichever

occurs later.

In the Federal Register of May 6,

1994, FDA categorized the penile

rigidity implant as a Group 2 device,

which FDA believes has a high potential

for being reclassified into class II. The

agency also announced its intent to

issue an order under section 515(i) of

the act for Group 2 devices.

In the Federal Register of August 14,

1995 (60 FR 41984 at 41986), FDA

published an order requiring

manufacturers of penile rigidity

implants to submit safety and

effectiveness information in accordance

with the Preamendments Class III

Strategy for implementing section 515(i)

of the act. On August 14, 1996, two
65772 Federal Register / Vol. 62, No. 241 / Tuesday, December 16, 1997 / Proposed Rules

summaries of safety and effectiveness

information were submitted to the

agency (Refs. 39 and 40). These

summaries recommended that the

penile rigidity implant be reclassified

into class II and provide information to

assist FDA in reclassifying this device.

In accordance with sections 513(e) of

the act and 21 CFR 860.130, based on

new information with respect to the

device, FDA, on its own initiative, is

proposing to reclassify this device from

class III to class II when intended to

provide penile rigidity in men

diagnosed as having erectile

dysfunction.

Consistent with the act and the

regulation, FDA did not refer, because of

the reasons stated herein, the proposed

reclassification to the Panel for its

recommendation on the requested

change in classification.

III. Device Description

A penile rigidity implant is a device

that consists of a pair of semi-rigid rods

implanted in the corpora cavernosa of

the penis to provide rigidity. It is

intended to be used in men diagnosed

as having erectile dysfunction.

The proposed rule to reclassify the

penile rigidity implant applies to legally

marketed penile rigidity implants

identified above that were commercially

distributed before May 28, 1976, and to

devices introduced into commercial

distribution since that date that have

been found to be substantially

equivalent to such penile rigidity

implants.

IV. Proposed Reclassification

FDA is proposing that the penile

rigidity implant be reclassified from

class III to class II. FDA believes that

class II with special controls

(specifically, the physician and patient

labeling, biocompatibility testing,

mechanical reliability performance

testing, clinical testing, and sterilization

requirements described in FDA’s

guidance document entitled ‘‘Guidance

for the Content of Premarket

Notifications for Penile Rigidity

Implants’’) would provide a reasonable

assurance of safety and effectiveness.

V. Risks to Health

After considering the information

discussed by the Panels during the

classification proceedings, as well as the

published literature, Medical Device

Reports, and 515(i) submissions of

safety and effectiveness information,

FDA has evaluated the risks associated

with the penile rigidity implant. FDA

now believes that the following are risks

associated with the use of the penile

rigidity implant:

A. Infection

Infection is a risk common to all

surgical procedures and implants. For

penile rigidity implants, infection is

typically reported to occur in 1 to 8

percent of cases (average of 3 percent)

(Refs. 3, 5, 7, 9, 13, 23, and 26). In most

cases, these infections result from

seeding at the time of surgery and are

reported as early post-operative

complications (Refs. 5 and 23).

However, late occurring prosthetic

infections have been noted, and they are

believed to be hematogenous in nature

as the result of dental or other surgical

procedures (Refs. 5, 6, 13, 17, and 23).

The best defense against infections is

prophylaxis, particularly the selection

of patients who are free of infection, the

administration of an intraoperative

shave and scrub, the use of

perioperative antibiotics, and adherence

to strict surgical technique (Refs. 5, 6,

18, 23, 26, and 32). However, even with

these preventive measures, certain

patients, such as those with a history of

urinary tract infection, are still at risk

for penile prosthesis infection (Refs. 5,

23, and 32).

The treatment of an infected penile

prosthesis is removal of the device

combined with appropriate antibiotic

medications (Refs. 21, 23, and 26). A

new device can either be placed at the

time of removal, or 3 to 12 months later

(Refs. 5, 7, 23, and 26). Sequela to penile

prosthesis infections include scarring/

fibrosis at the site of the prior implant,

which could make reimplantation of a

penile rigidity implant difficult (Refs. 21

and 30). Serious sequela are rare (Ref.

11).

B. Erosion, Migration, and Extrusion

Erosion refers to the breakdown of

tissue adjacent to the device. Migration

refers to the movement of the implant

within the body. In some cases, erosion

may result in the external migration of

the device, which is called extrusion.

Erosion, migration, and extrusion of a

penile rigidity implant are uncommon

(<3 percent) complications (Ref. 28).

Erosion and/or extrusion usually occur

distally through either the urethra or the

glans penis (Ref. 26). Proximal

migration of the device without erosion

or extrusion can result in inadequate

support of the glans penis (often called

‘‘floppy glans’’ or ‘‘SST deformity’’)

(Refs. 28 and 31).

Factors contributing to erosion,

migration, or extrusion include

implantation of a device that is too

large, iatrogenic injury to the

surrounding tissues (i.e., urethra,

corpora, etc.), and infection (Refs. 26,

27, and 28). Additionally, it is possible

that malfunction of the implant could

lead to erosion, migration, or extrusion

if rough or sharp edges are created or

front/rear tips extenders become

detached. Other risk factors include

previous pelvic surgery, pelvic

radiation, and spinal cord injury (Refs.

28 and 35).

Treatment of an eroded, migrated, or

extruded device consists of removal of

the device, antibiotic treatment, and

supportive care (Refs. 21, 26, and 28). If

the condition is not treated in a timely

manner, the condition may worsen,

leading to infection and loss of tissue

(Ref. 21).

C. Mechanical Malfunction

As with other prosthetic devices

intended to restore a physiologic

function, penile rigidity implants may

malfunction mechanically. Rates for

mechanical malfunction vary with the

type and model of penile rigidity

implant, and are believed to be

significantly lower now than they were

with previous models due to

improvements in design (Refs. 14, 17,

and 27). Mechanical malfunction may

be caused by improper device handling

or surgical technique, or problems with

the device’s design or manufacturing

process (Ref. 27).

Mechanical malfunctions may affect

device effectiveness in terms of

decreases in device positionability,

implant rigidity or column strength, or

length of the prosthesis (Refs. 1, 14, 19,

24, 25, and 36). Surgical intervention to

remove and replace the device is

required if the patient desires a working

prosthesis (Refs. 1, 33, and 36).

D. Patient Dissatisfaction

If patients are not provided

information and counseled about the

risks and benefits of the penile rigidity

implant prior to implantation, they may

not have realistic expectations of the

physical, psychological, and functional

outcomes of the implant (Refs. 15, 26,

and 30). Uninformed patients may be

dissatisfied with the outcome in terms

of size, shape, and rigidity of the

prosthetic erection; concealability of the

penis; penile scarring; penile sensation;

the chance that any latent erectile

capability will be lost following surgery;

or other performance characteristics

(Refs. 17, 21, 26, and 34). Some

dissatisfied patients have requested

removal of a device that was functioning

according to the manufacturer’s

specifications because the implant did

not meet their expectations (Refs. 9 and

22). With proper counseling, however,

patient satisfaction with penile rigidity

implants is typically in the range of 85
Federal Register / Vol. 62, No. 241 / Tuesday, December 16, 1997 / Proposed Rules 65773

to 91 percent (Refs. 8, 12, 14, 16, 17, and

37).

E. Adverse Tissue Reaction

If the materials used in the

construction of the device are not

biocompatible, the patient may have an

adverse tissue reaction. This risk is not

unique to penile rigidity implants, as

patients may have an adverse tissue or

sensitivity reaction to any implanted

device. Since the time that the penile

rigidity implant was originally

classified, few reports of adverse tissue

reaction have been reported (Ref. 19).

Surgical removal of the implant is

generally indicated in patients

experiencing prolonged discomfort or

pain due to biocompatibility issues

associated with device materials.

F. Prolonged or Intractable Pain

As would be expected for any

implant, surgical placement of a penile

rigidity implant results in temporary

pain at the operative sites during the

recovery period. Infrequently, however,

cases of prolonged or intractable postoperative pain associated with device

implantation have also been reported

(Ref. 22). Persistent or worsening pain

beyond the 4 to 6-week-post-operative

healing period is symptomatic of

possible infection (Refs. 23 and 29).

However, studies have noted cases with

persistent pain and subsequent device

removal for which culture results were

negative (Ref. 14). It is possible that pain

can also be symptomatic of adverse

tissue reaction, mechanical malfunction,

or incorrect sizing of the device.

Prolonged or intractable pain may lead

to surgical intervention with device

removal.

G. Urinary Obstruction

If the prosthesis compresses the

urethra, urine flow could be impeded

(Ref. 8). However, since the time that

the penile rigidity implant was

originally classified, reports of urinary

obstruction secondary to implantation

of a penile rigidity implant have been

rare (Ref. 19). This complication may

occur if the implant is improperly sized

or malpositioned by the implanting

physician. Surgical intervention may be

indicated in patients experiencing

urinary obstruction associated with the

presence of the device.

H. Silicone Particle Migration

The patient-contacting surfaces of

penile rigidity implants consist

primarily of silicone elastomers. Neither

silicone gel nor liquid are used in the

construction of these devices. The

migration of silicone particles from the

solid elastomer exterior of various

penile prostheses has been described by

Barrett et al. (Ref. 2). Although particles

of silicone were found in the tissues

adjacent to the device and in draining

lymph nodes in some patients, no

deleterious effects have been associated

with this finding to date. In a related

study by Fishman et al., patients with

pre-existing penile implants underwent

pelvic lymph node dissection for

reasons unrelated to the implant (Ref.

10). Microscopic examination of the

lymph nodes showed no evidence of

silicone elastomer migration.

Since the time that the reasons for

placing penile rigidity implants into

class III were first summarized, no

adverse reactions related to silicone

particle migration have been

documented. Therefore, it appears that

this theoretical risk may not be an actual

risk of penile rigidity implants.

I. Other Complications

Other infrequently reported

complications of the penile rigidity

implant include post-operative

bleeding, hematoma, penile edema, and

penile necrosis/gangrene (Refs. 3, 19,

20, 26, and 36). Intraoperative

complications have also been noted,

which include perforation of the

corpora or the urethra, inability to

adequately dilate the corpora, incorrect

sizing of the implant, and tearing or

ripping the device during implantation

(Refs. 5, 19, 26, 30, and 36). All of these

complications can be reduced by good

patient selection and careful surgical

technique.

VI. Summary of Reasons for

Reclassification

FDA believes the penile rigidity

implant should be classified into class

II because special controls, in addition

to general controls, provide reasonable

assurance of the safety and effectiveness

of the device, and there is sufficient

information to establish special controls

to provide such assurance.

VII. Summary of Data Upon Which the

Reclassification is Based

In addition to the potential risks of

the penile rigidity implant described in

section V of this document, there is

reasonable knowledge of the benefits of

the device. Specifically, placement of

the penile rigidity implant in men with

erectile dysfunction typically provides

sufficient penile rigidity for vaginal

intercourse. Furthermore, satisfaction

rates in excess of 90 percent have been

reported among penile rigidity implant

recipients (Refs. 8, 12, 14, 16, 17, and

37).

Based on the available information,

FDA believes that the special controls

discussed in section VIII of this

document are capable of providing

reasonable assurance of the safety and

effectiveness of the penile rigidity

implant with regard to the identified

risks to health of this device.

VIII. Special Controls

In addition to general controls, FDA

believes that the guidance document

entitled, ‘‘Guidance for the Content of

Premarket Notifications for Penile

Rigidity Implants’’ (Ref. 38) is an

adequate special control to address the

risks to health described in section V of

this document.

This guidance document addresses

the following: (1) Physician labeling, (2)

patient labeling, (3) biocompatibility

testing, (4) mechanical testing, (5)

clinical data requirements, and (6)

sterilization procedures and labeling.

A. Physician labeling

The physician labeling section of the

guidance document can help control the

risks of infection, erosion, migration,

extrusion, mechanical malfunction,

patient dissatisfaction, prolonged or

intractable pain, urinary obstruction,

silicone particle migration, and other

miscellaneous clinical complications by

having the manufacturer provide

information on: (1) The proper handling

of the device prior to implantation, (2)

selection and preparation of the patient,

(3) surgical and sterile technique, (4)

implant sizing, (5) care of the implant

site during and after the recovery

period, (6) post-operative use of the

device, (7) how to recognize and

minimize these potential complications,

(8) the normal healing process, and (9)

the realistic outcomes of the penile

rigidity implant.

B. Patient labeling

The patient labeling section of the

guidance document can help control the

risks of infection, erosion, migration,

extrusion, mechanical malfunction,

patient dissatisfaction, prolonged or

intractable pain, urinary obstruction,

silicone particle migration, and other

miscellaneous clinical complications by

having the manufacturer provide

prospective patients information on: (1)

Care of the implant site during and after

the recovery period, (2) post-operative

use of the device, (3) how to recognize

and minimize these potential

complications, (4) the normal healing

process, and (5) the realistic outcomes

of the penile rigidity implant.

C. Biocompatibility testing

Adherence to the biocompatibility

testing section of the guidance

document can control the risk of
65774 Federal Register / Vol. 62, No. 241 / Tuesday, December 16, 1997 / Proposed Rules

adverse tissue reaction by having the

manufacturer demonstrate that the

patient contacting materials of the

penile rigidity implant are safe for longterm implantation.

D. Mechanical testing

Adherence to the mechanical testing

section of the guidance document can

help control the risks of erosion,

migration, extrusion, and mechanical

malfunction by demonstrating the

reliability of the device.

E. Clinical data requirements

For penile rigidity implants that are

significantly different from devices

already on the market, the clinical data

requirements section of the guidance

document can help control the risks of

infection, erosion, migration, extrusion,

mechanical malfunction, and prolonged

or intractable pain by determining

whether these risks are within the limits

established by existing devices.

F. Sterilization procedures and labeling

Adherence to the sterilization

procedures and labeling section of the

guidance document can help control the

risk of infection by guarding against the

implantation of an unsterile device.

IX. 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 am. and 4 pm., Monday

through Friday.

1. Agatstein, E. H., J. H. Farrer, and S. Raz,

‘‘Fracture of Semirigid Penile Prosthesis: A

Rare Complication,’’ The Journal of Urology,

135:376–377, 1986.

2. Barrett, D. M., D. C. O’Sullivan, A. A.

Malizia, H. M. Reiman, and P. C. Abell-Aleff,

‘‘Particle Shedding and Migration from

Silicone Genitourinary Prosthetic Devices,’’

The Journal of Urology, 146:319–322, 1991.

3. Benjany, D. E., P. E. Perito, M.

Lustgarten, and R. K. Rhamy, ‘‘Gangrene of

the Penis after Implantation of Penile

Prosthesis: Case Reports, Treatment

Recommendations and Review of the

Literature,’’ The Journal of Urology, 150:190–

192, 1993.

4. Blue book memorandum #G95–1, ‘‘Use

of International Standard ISO–10993,

‘Biological Evaluation of Medical Devices

Part 1: Evaluation and Testing,’’’ FDA.

5. Blum, M. D., ‘‘Infections of

Genitourinary Prostheses,’’ Infectious Disease

Clinics of North America, 3(2):259–274,

1989.

6. Carson, C. C., ‘‘Infections in

Genitourinary Prostheses,’’ Urologic Clinics

of North America, 16(1):139–147, 1989.

7. Choi, H. K., I. R. Cho, and Z. C. Xin,

‘‘Ten Years of Experience with Various

Penile Prosthesis in Korean,’’ Ynsei Medical

Journal, 35(2):209–217, 1994.

8. Dorflinger, T., and R. Bruskewitz, ‘‘AMS

Malleable Penile Prosthesis,’’ Urology,

28(6):480–485, 1986.

9. Earle, C. M., G. R. Watters, A. G. S.

Tulloch, Z. S. Wisniewski, D. J. Lord, and E.

J. Keogh, ‘‘Complications Associated with

Penile Implants Used to Treat Impotence,’’

Australian and New Zealand Journal of

Surgery, 59:959–962, 1989.

10. Fishman, I. J., and F. N. Flores,

‘‘Retrospective Review of Pelvic Lymph

Nodes in Patients with Previously Implanted

Silicone Penile Prosthesis,’’ The Journal of

Urology, 149:355A, 1993.

11. Goldman, J. M., and M. F. Wheeler,

‘‘Primary Renal Candidiasis Associated with

a Penile Prosthesis in a Diabetic Man,’’ The

Journal of Diabetic Complications, 3:179–

180, 1989.

12. Hrebrinko, R, R. R. Bahnson, F. N.

Schwentker, and W. F. O’Donnell, ‘‘Early

Experience with the Duraphase Penile

Prosthesis,’’ The Journal of Urology, 143:60–

61, 1990.

13. Kabalin, J. N., and R. Kessler,

‘‘Infectious Complications of Penile

Prosthesis Surgery,’’ The Journal of Urology,

139:953–955, 1988.

14. Kearse, W. S., Jr., A. L. Sago, S. J.

Peretsman, J. O. Bolton, R. G. Holcomb, P. K.

Reddy, P. H. Bernhard, S. M. Eppel, J. H.

Lewis, M. Gladshteyn, and A. A. Melman,

‘‘Report of a Multicenter Clinical Evaluation

of the Dura-II Penile Prosthesis,’’ The Journal

of Urology, 155:1–4, 1996.

15. Kramarsky—Binkhorst, S., ‘‘Female

Partner Perception of Small—Carrion

Implant,’’ Urology, 12(5):545–548, 1978.

16. Krauss, D. J., L. J. Lantinga, M. P. Carey,

A. W. Meisler, and C. M. Kelly, ‘‘Use of the

Malleable Penile Prosthesis in the Treatment

of Erectile Dysfunction,’’ 142:988–991, 1989.

17. Lewis, R. W., ‘‘Long-Term Results of

Penile Prosthetic Implants,’’ Urologic Clinics

of North America, 22(4):847–856, 1995.

18. Lynch, M. J., G. M. Scott, J. A. Inglis,

and J. P. Pryor, ‘‘Reducing the Loss of

Implants Following Penile Prosthetic

Surgery,’’ British Journal of Urology, 73:423–

427, 1994.

19. Medical Device Reporting (MDR) and

Product Problem Reporting (PPR), Device

Experience Network (DEN), FDA.

20. Melman, A., ‘‘Experience with

Implantation of the Small—Carrion Penile

Implant for Organic Impotence,’’ The Journal

of Urology, 116:49–50, 1976.

21. Montague, D. K., ‘‘Penile Prostheses.

An Overview.,’’ Urologic Clinics of North

America, 16(1):7–12, 1989.

22. Moul, J. W., and D. G. McLeod,

‘‘Experience with the AMS 600 Malleable

Penile Prosthesis,’’ The Journal of Urology,

135:929–931, 1986.

23. Mulcahy, J. J., M. D. Brant, and J. K.

Ludlow, ‘‘Management of Infected Penile

Implants,’’ Techniques in Urology, 1(3):115–

119, 1995.

24. Mulcahy, J. J., R. J. Krane, L. K. Lloyd,

M. Edson, and M. B. Siroky, ‘‘Duraphase

Penile Prosthesis—Results of Clinical Trials

in 63 Patients,’’ The Journal of Urology,

143:518–519, 1990.

25. Mulcahy, J. J., ‘‘Mechanical Penile

Prostheses,’’ Problems in Urology, 7(3):311–

316, 1993.

26. Mulcahy, J. J., ‘‘The Management of

Complications of Penile Implants,’’ Problems

in Urology, 5(4)608–627, 1991.

27. Nielsen, K. T., and R. C. Bruskewitz,

‘‘Semirigid and Malleable Rod Penile

Prostheses,’’ Urologic Clinics of North

America, 16(1):13–23, 1989.

28. Oesterling, J. E., ‘‘A Simple Technique

for Removal of Eroded Penile Prostheses,’’

The Journal of Urology, 142:1538–1539,

1989.

29. Parsons, C. L., P. C. Stein, M. K. Dobke,

C. P. Virden, and D. H. Frank, ‘‘Diagnosis and

Therapy of Subclinically Infected

Prostheses,’’ Surgery, Gynecology &

Obstetrics, 177:504–506, 1993.

30. Petrou, S. P., and D. M. Barrett, ‘‘The

Use of Penile Prostheses in Erectile

Dysfunction,’’ Seminars in Urology, 8(2):138–

152, 1990.

31. Quinn, A. D., and S. Das, ‘‘Proximal

Extrusion of Semirigid Penile Prosthesis,’’

Scandinavian Journal of Urology and

Nephrology, 23:239–240, 1989.

32. Radomski, S. B., and S. Herschorn,

‘‘Risk Factors Associated with Penile

Prosthesis Infection,’’ The Journal of Urology,

147:383–385, 1992.

33. Reisner, G. S., ‘‘Experience with Penile

Prostheses in 107 Patients,’’ British Journal of

Urology (Abstract), 65:87, 1990.

34. Steege, J. F., A. L. Stout, and C. C.

Carson, ‘‘Patient Satisfaction in Scott and

Small—Carrion Penile Implant Recipients: A

Study of 52 Patients,’’ Archives of Sexual

Behavior, 15(5):393–399, 1986.

35. Steidle, C. P., and J. J. Mulcahy,

‘‘Erosion of Penile Prostheses: A

Complication of Urethral Catheterization,’’

The Journal of Urology, 142:736–739, 1989.

36. Tawil, E. A., and J. G. Gregory, ‘‘Failure

of the Jonas Prosthesis,’’ The Journal of

Urology, 135:702–703, 1985.

37. Thompson, I. M., F. R. Rodriguez, and

E. J. Zeidman, ‘‘Experience with Duraphase

Penile Prosthesis: Its Use as Replacement

Device,’’ Urology, 36(6):505–507, 1990.

38. ‘‘Guidance on the Content of Premarket

Notifications for Penile Rigidity Implants,’’

revised December 9, 1996, FDA.

39. Health Industry Manufacturers

Association, 515(i) Submission of Safety and

Effectiveness, Docket No. 94N–0417, August

14, 1996.

40. Mentor Corp., 515(i) Submission of

Safety and Effectiveness, Docket No. 94N–

0417, August 14, 1996.

X. Environmental Impact

The agency has determined under 21

CFR 25.24(e)(2) 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.

XI. 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
Federal Register / Vol. 62, No. 241 / Tuesday, December 16, 1997 / Proposed Rules 65775

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

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. Reclassification of this device

from class III to class II will relieve all

manufacturers of the device of the cost

of complying with the premarket

approval requirements in section 515 of

the act. Because reclassification will

reduce regulatory costs with respect to

this device, it will impose no significant

economic impact on any small entities,

and it may permit small potential

competitors to enter the marketplace by

lowering their costs. The agency

therefore certifies that the final rule will

not have a significant economic impact

on a substantial number of small

entities. The rule also does not trigger

the requirement for a written statement

under section 202(a) of the Unfunded

Mandates Reform Act because it does

not impose a mandate that results in an

expenditure of $100 million or more by

State, local, or tribal governments in the

aggregate, or by the private sector, in

any 1 year.

XII. Comments

Interested persons may, on or before

March 16, 1998 submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. Two copies of any comments

are to be submitted except that

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—GASTROENTEROLOGYUROLOGY 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 876.3630 is revised to read

as follows:

§ 876.3630 Penile rigidity implant.

(a) Identification. A penile rigidity

implant is a device that consists of a

pair of semi-rigid rods implanted in the

corpora cavernosa of the penis to

provide rigidity. It is intended to be

used in men diagnosed as having

erectile dysfunction. (b) Classification.

Class II (special controls) (premarket

notification guidance).

Dated: November 11, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–32809 Filed 12-15-97; 8:45 am]

BILLING CODE 4160–01–F

NATIONAL INDIAN GAMING

COMMISSION

25 CFR Part 514

Annual Fees Payable By Indian

Gaming Operations

AGENCY: National Indian Gaming

Commission.

ACTION: Proposed rule.

SUMMARY: The National Indian Gaming

Commission is proposing to amend its

fee regulations to add class III gaming

revenues to the assessable gross revenue

base, increase the total amount of fees

that can be imposed, and provide for an

exemption for self-regulated tribes such

as the Mississippi Band of Choctaw.

This action is being taken pursuant to

recent amendments to the Indian

Gaming Regulatory Act. The primary

effect of this action is to increase the

funding for the National Indian Gaming

Commission.

DATES: Comments must be submitted on

or before January 15, 1998.

ADDRESSES: Comments may be mailed

to: Fee Regulation Comments, National

Indian Gaming Commission, 1441 L

Street, N.W., Suite 9100, Washington,

DC 20005, delivered to that address

between 8:30 a.m. and 5:30 p.m.,

Monday through Friday, or faxed to

202/632–7066 (this is not a toll-free

number). Comments received may be

inspected between 9 a.m. and noon, and

between 2 p.m. and 5 p.m.

FOR FURTHER INFORMATION CONTACT:

Fred W. Stuckwisch at 202/632–7003;

fax 202/632–7066 (these are not toll-free

numbers).

SUPPLEMENTARY INFORMATION: The

Indian Gaming Regulatory Act (IGRA),

enacted on October 17, 1988,

established the National Indian Gaming

Commission (Commission). The

Commission is charged with, among

other things, regulating gaming on

Indian lands. Pursuant to recent

amendments to the IGRA, these fee

regulations are being amended to:

(1) Add class III gaming revenues to

the assessable gross revenue base,

(2) Increase the total amount of fees

that can be imposed, and

(3) Provide an exemption for selfregulated tribes such as the Mississippi

Band of Choctaw.

As a result, gaming operations

offering only class III games must begin

reporting and paying fees, and gaming

operations offering both class II and III

games must begin reporting and paying

fees on their class III revenues.

The Commission has adopted a 30

day comment period for this proposed

rule because (1) the basic rule has been

in effect for six (6) years, (2) comments

were received and considered before the

basic rule was adopted, and (3) it is

important that the increased funding for

the Commission as enacted by Congress

be implemented as soon as possible.

The purpose of these regulations is to

implement those portions of IGRA that

provide for the payment of fees by

gaming operations and for the collection

and use of such fees by the Commission.

Gaming operations are the economic

entities that are licensed by a tribe,

operate the games, receive the revenues,

issue the prizes, and pay the expenses.

Gaming operations may be operated by

a tribe directly, by a management

contractor, or in the case of certain

grandfathered class II gaming

operations, by an individual owner/

operator.

These regulations provide for a

system of fee assessment and payment

that is self-administered by the gaming

operations. Briefly, the Commission

adopts and communicates the

assessment rates; the gaming operations

apply those rates to their revenues,

compute the fees to be paid, and report

and remit the fees to the Commission on

a quarterly basis.

Annual fees are payable quarterly

each calendar year based on the

previous calendar year’s class II and III

assessable gross revenues from the

gaming operations.