[Federal Register Volume 62, Number 241 (Tuesday, December 16, 1997)]
[Proposed Rules]
[Pages 65770-65775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32809]


=======================================================================
-----------------------------------------------------------------------

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.

[[Page 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

[[Page 65772]]

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

[[Page 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 post-operative 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

[[Page 65774]]

adverse tissue reaction by having the manufacturer demonstrate that the 
patient contacting materials of the penile rigidity implant are safe 
for long-term 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

[[Page 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--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 876.3630 is revised to read as follows:

Sec. 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