[Federal Register Volume 65, Number 187 (Tuesday, September 26, 2000)]
[Rules and Regulations]
[Pages 57726-57732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24632]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. 94N-0380]


Gastroenterology and Urology Devices; Effective Date of 
Requirement for Premarket Approval of the Implanted Mechanical/
Hydraulic Urinary Continence Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
to require the filing of a premarket approval application (PMA) or a 
notice of completion of a product development protocol (PDP) for the 
implanted mechanical/hydraulic urinary continence device, a generic 
type of medical device intended for the treatment of urinary 
incontinence. 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 amendments), the Safe Medical Devices Act of 1990 (the 
SMDA), and the Food and Drug Administration Modernization Act of 1997.

EFFECTIVE DATE: This rule is effective October 26, 2000.

FOR FURTHER INFORMATION CONTACT: Nicole L. Wolanski, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2194.

SUPPLEMENTARY INFORMATION:

I. Introduction

    SMDA added new section 515(i) to the act (21 U.S.C. 360e(i)). This 
section requires FDA to review the classification of preamendments 
class III devices for which no final rule has been issued requiring the 
submission of PMA's and to determine whether each device should be 
reclassified into class I or class II or remain in class III. For 
devices remaining in class III, SMDA directed FDA to develop a schedule 
for issuing regulations to require premarket approval.
    In the Federal Register of November 23, 1983 (48 FR 53032), FDA 
published a final rule classifying into class III (premarket approval) 
the implanted mechanical/hydraulic urinary continence device, a medical 
device. Section 876.5280 (21 CFR 876.5280) of FDA's regulations setting 
forth the classification of the implanted mechanical/hydraulic urinary 
continence device applies to: (1) Any implanted mechanical/hydraulic 
urinary continence device that was in commercial distribution before 
May 28, 1976, and (2) any device that FDA has found to be substantially 
equivalent to an implanted mechanical/hydraulic urinary continence 
device in commercial distribution before May 28, 1976.
    In the Federal Register of February 15, 1995 (60 FR 8595), FDA 
published a proposed rule, under section 515(b) of the act (21 U.S.C. 
360e(b)), to require the filing of PMA's or PDP's for the classified 
implanted mechanical/hydraulic urinary continence device and all 
substantially equivalent devices. In accordance with section 
515(b)(2)(A) of the act, FDA included in the preamble, the agency's 
proposed findings regarding: (1) The degree of risk of illness or 
injury designed to be eliminated or reduced by requiring the device to 
meet the premarket approval requirements of the act, and (2) the 
benefits to the public from use of the device.
    The preamble also provided an opportunity for interested persons to 
submit comments on the proposed rule and the agency's proposed 
findings. Under section 515(b)(2)(B) of the act, it also provided an 
opportunity for interested persons to request a change in the 
classification of the device based on new information relevant to its 
classification. Any petition requesting a change in the classification 
of the implanted mechanical/hydraulic urinary continence device was 
required to be submitted by March 2, 1995. The comment period closed on 
June 15, 1995.
    The agency received three comments in response to the February 15, 
1995, proposed rule. These comments were from physicians and a 
manufacturer. These three comments raised numerous issues. A summary of 
the comments and FDA's responses are set out below.
    This regulation is final upon publication and requires PMA's or 
notices of completion of a PDP for all implanted mechanical/hydraulic 
urinary continence devices classified under Sec. 876.5280 and all 
devices that are substantially equivalent to them. PMA's or notices of 
completion of a PDP for these devices must be filed with FDA within 90 
days of the effective date of this regulation. (See section 
501(f)(1)(A) of the act (21 U.S.C. 351(f)(1)(A)).)

[[Page 57727]]

II. Summary and Analysis of Comments and FDA's Response

A. General Comments

    (Comment 1) FDA received two comments from individual physicians. 
Although these comments did not object to the proposed call for PMA's 
or PDP's, they voiced the following common concerns: (1) The implanted 
mechanical/hydraulic urinary continence device is intended for those 
with severe urinary incontinence, in whom other modalities are 
unsuccessful, (2) removal of this device from the U.S. market would be 
detrimental to public health, and (3) citing the 20 years of use of the 
device, sufficient historical data exist to evaluate the safety and 
effectiveness of the implanted mechanical/hydraulic urinary continence 
device. This last concern was also noted in a comment from an implanted 
mechanical/hydraulic urinary continence device manufacturer, which 
stated that the decades of medical literature regarding the risks and 
benefits of this device provide sufficient evidence of its safety and 
effectiveness. The comments remarked that FDA has overstated the risks 
of the implanted mechanical/hydraulic urinary continence device, that 
the studies are costly and unnecessary, and that the agency can rely on 
MDR reports or use its authority to ask for post-market surveillance on 
510(k) products.
    FDA agrees that urinary incontinence is a significant medical 
problem that negatively affects the lives of many men and women in the 
United States. Furthermore, since implanted mechanical/hydraulic 
urinary continence devices represent an important option in the 
treatment of severe urinary incontinence, FDA agrees with these 
comments that removal of the implanted mechanical/hydraulic urinary 
continence device from the market would negatively impact public 
health. As a result of this concern, FDA has taken the following steps 
to promote the continued availability of the implanted mechanical/
hydraulic urinary continence device during the call for PMA's or PDP's: 
(1) FDA issued the guidance document entitled ``Draft Guidance For 
Preparation Of PMA Applications For The Implanted Mechanical/Hydraulic 
Urinary Continence Device(Artificial Urinary Sphincter)'' in May 1995 
(the 1995 guidance document) to provide industry with detailed 
recommendations on the content of PMA's; (2) FDA has communicated 
closely with each implanted mechanical/hydraulic urinary continence 
device manufacturer to address the concerns identified in the proposed 
rule using least burdensome methods, as well as provide recommendations 
on the design of preclinical and clinical studies; and (3) FDA 
intentionally postponed the call for PMA's or PDP's to allow 
manufacturers to collect sufficient data to support the filing of a PMA 
or PDP.
    FDA agrees with the comments that there is a significant amount of 
information in the published and unpublished literature regarding the 
implanted mechanical/hydraulic urinary continence device. However, to 
FDA's knowledge, these studies are neither sufficiently detailed nor 
properly designed to perform a statistically valid evaluation of safety 
and effectiveness. As recommended in the 1995 guidance document, PMA's 
or PDP's should contain safety and effectiveness information on the 
specific device model(s) proposed in the application.
    Although a large body of historical data exists regarding the 
clinical outcomes of models of implanted mechanical/hydraulic urinary 
continence devices that are no longer marketed, there is less 
information available regarding the safety and effectiveness of 
currently-marketed models. However, if sufficient historical 
information exists to document the safety and effectiveness of a 
particular implanted mechanical/hydraulic urinary continence device 
model that a manufacturer desires to market, or if data about earlier 
models are directly relevant to a particular device, FDA encourages the 
use of this data in support of a PMA or PDP for that model.
    While FDA agrees that the proposed rule may have overstated the 
risks of some of the specific implanted mechanical/hydraulic urinary 
continence device models that are currently on the market, we believe 
that the information in the proposed rule represents a reasonable 
estimate of the risks and benefits of the entire category of implanted 
mechanical/hydraulic urinary continence devices. As noted in many of 
these comments, manufacturers have made numerous design modifications 
to improve the reliability of the implanted mechanical/hydraulic 
urinary continence device and the medical community continues to 
improve the patient selection criteria, patient counseling information, 
operative technique, and post-operative care to reduce the incidence of 
complications. Therefore, FDA expects the rates of complications 
reported in PMA's or PDP's for particular implanted mechanical/
hydraulic urinary continence devices to be lower than estimated from a 
review of the literature on the entire device category. However, in 
writing the proposed call for PMA's or PDP's, FDA must consider the 
risks and benefits of all implanted mechanical/hydraulic urinary 
continence devices that currently have the status of being legally 
marketed in the United States.
    While FDA acknowledges that MDR reports and post-market 
surveillance are valuable tools for obtaining information on devices, 
FDA believes that additional data are necessary to establish the safety 
and effectiveness for the implanted mechanical/hydraulic urinary 
continence device and that these data should be submitted and evaluated 
within a PMA or PDP.

B. Erosion

    (Comment 2) There was one comment regarding the risk of erosion. 
This comment stated that erosion of the implanted mechanical/hydraulic 
urinary continence device occurs infrequently, and for reasons that are 
not inherent in the device, but instead may be due to a variety of 
conditions that are characteristic of some patients, e.g., as a result 
of scar tissue and/or eradiated tissue. The comment further stated that 
erosion is reported to occur at low rates which are within acceptable 
limits.
    While FDA agrees that the risk of erosion may be small, 
insufficient information is available to determine the frequency of 
this event or its consequences. Therefore, FDA believes that it is 
important for studies submitted in a PMA or PDP to provide accurate 
information on the incidence of erosion associated with the 
implantation of the implanted mechanical/hydraulic urinary continence 
device. As noted in the 1995 guidance document, FDA is requesting 
information to address the incidence of erosion for this device.

C. Infection

    (Comment 3) There was one comment on the risk of infection. This 
comment agreed with the proposed rule in acknowledging that infections 
are not necessarily caused by the device, citing that surgical 
infections are also reported.
    FDA believes that proper patient selection, surgical precautions, 
and post- operative care can minimize the risk of infection. FDA also 
believes that it is important for studies submitted in a PMA or PDP to 
provide accurate information on the incidence and consequences of 
infection associated with the implantation of the implanted mechanical/
hydraulic urinary continence device. As noted in the 1995

[[Page 57728]]

guidance document, FDA is requesting information on the incidence of 
infection for this device.

D. Hydronephrosis

    (Comment 4) There were three comments regarding the risk of 
hydronephrosis. These comments stated that the occurrence of 
hydronephrosis is rare and generally a risk only to those with urinary 
incontinence owing to neurogenic bladder if they have decreased bladder 
compliance before implantation. Therefore, this risk can be addressed 
by contraindicating use of the device in patients with decreased 
bladder compliance and closely monitoring all implant recipients who 
have neurogenic bladders. Also, one comment indicated that the presence 
and normal use of the implanted mechanical/hydraulic urinary continence 
device does not create a negative obstruction to the neurogenic bladder 
any more than a normally functioning internal sphincter and therefore, 
the use of the device does not create an additional risk for 
hydronephrosis that was not already present in this group of patients. 
Another comment stated that new solutions bring new risks and new 
problems, and the benefit of continence is well worth the risks. Two 
comments cited the need for appropriate followup.
    FDA agrees that the majority of patients who experience 
hydronephrosis have been diagnosed with some type of nerve or spinal 
cord damage. Additionally, FDA concurs with the comments that patients 
with decreased bladder compliance should not receive an implanted 
mechanical/hydraulic urinary continence device. However, since 
hydronephrosis can ultimately lead to kidney damage and require 
surgical intervention, FDA considers hydronephrosis a serious risk to 
health. To assess the risk/benefit ratio of an implanted mechanical/
hydraulic urinary continence device, FDA believes it is essential to 
evaluate the frequency of this event and its consequences. Therefore, 
FDA believes it is important for studies submitted in a PMA or PDP to 
provide accurate information on the pathogenesis and incidence of 
hydronephrosis with the implantation of the implanted mechanical/
hydraulic urinary continence device.

E. Human Carcinogenicity

    (Comment 5) There was one comment regarding the risk of human 
carcinogenicity. This comment stated that there is no evidence in the 
medical literature that the implanted mechanical/hydraulic urinary 
continence device is associated with the development of cancer. This 
comment further stated that silicone causes solid state tumors in 
animals, a phenomenon thought to be restricted to animals and not 
applicable to humans. The comment also stated that epidemiological 
studies have not found that women with silicone breast implants, which 
contain silicone elastomers similar or identical to those used in the 
implanted mechanical/hydraulic urinary continence device, are at an 
increased risk for cancer and that human carcinogenicity should be 
removed from the list of significant risks associated with the 
implanted mechanical/hydraulic urinary continence device.
    FDA believes that the potential carcinogenicity for this device 
remains unknown. The agency continues to believe that carcinogenicity 
is a potential risk that should be addressed in a PMA or PDP.

F. Human Reproductive and Teratogenic Effects

    (Comment 6) There was one comment related to human reproductive and 
teratogenic effects. This comment stated that there is no evidence that 
the implanted mechanical/hydraulic urinary continence device is 
antiandrogenic or teratogenic. This comment also stated that since most 
implant patients are male, any effects on reproduction or development 
of offspring must be mediated largely by effects on the male 
spermatozoa or on male libido. This comment further stated that human 
reproductive and teratogenic effects should be removed from the list of 
significant risks associated with the implanted mechanical/hydraulic 
urinary continence device.
    FDA agrees that there are no published studies showing that 
implanted mechanical/hydraulic urinary continence devices are 
associated with toxic reproductive effects or teratogenic effects. 
However, FDA believes that the reproductive and/or teratogenic effects 
of these products remain potential risks that should be addressed in a 
PMA or PDP.

G. Immune Related Connective Tissue Disorders--Immunological 
Sensitization

    (Comment 7) There was one comment regarding the risks of immune 
related connective tissue disorders and immunological sensitization. 
This comment stated that there is no evidence that the implanted 
mechanical/hydraulic urinary continence device causes either immune 
related connective tissue disorders or immunological sensitization and 
that no definitive link between silicone and autoimmune diseases has 
been established. Furthermore, this comment stated that since the 
diseases most frequently associated with autoimmune responses occur at 
a lower frequency in men than women, it may be impossible to 
extrapolate the findings from any study of silicone breast implants to 
the implanted mechanical/hydraulic urinary continence device. This 
comment stated that immune related connective tissue disorders and 
immunological sensitization should be removed from the list of 
significant risks associated with the implanted mechanical/hydraulic 
urinary continence device.
    FDA agrees that no definitive causal relationship has been 
established between immunological effects and/or connective tissue 
disorders and the implanted mechanical/hydraulic urinary continence 
device. Epidemiological data published within the last several years 
(Refs. 3, 4 and 5) addressing the relationship between silicone breast 
prostheses and autoimmune diseases or connective tissue diseases 
indicate that silicone breast prostheses have not caused a large 
increase in the incidence of connective tissue disease in women with 
breast implants. However, the possibility of a smaller, increased risk 
of immunological effects among patients with implanted mechanical/
hydraulic urinary continence devices, or of an atypical, as yet 
undefined, syndrome or disease, cannot be eliminated based on these 
data.
    FDA is aware that differences between the incidence of autoimmune 
diseases or connective tissue diseases in men and women make it 
difficult to extrapolate the results of breast implant studies (in 
women) to prospective outcomes of the implanted mechanical/hydraulic 
urinary continence device (in men and women). In the 1995 guidance 
document, FDA recommends that a cohort of implanted mechanical/
hydraulic urinary continence device recipients be regularly monitored 
for the occurrence of such adverse events as part of an active 
surveillance program for a minimum of 5 years postimplantation. FDA 
continues to believe that adverse immune related connective tissue 
disorders and immunological sensitization remain potential risks that 
must be assessed in a PMA or PDP, but FDA does not believe that 5 years 
of prospective data collection on a specific product will be necessary 
for PMA approval or PDP completion.

[[Page 57729]]

H. Biological Effects of Silica

    (Comment 8) One comment stated that fumed amorphous silica is so 
tightly bound in the silicone elastomer components of the implanted 
mechanical/hydraulic urinary continence device that the fumed amorphous 
silica is biologically inactive. For that reason, this comment believed 
that the presence of fumed amorphous silica is not a risk to health of 
the implanted mechanical/hydraulic urinary continence device. This 
comment also stated that complications related to the release of silica 
from the implanted mechanical/hydraulic urinary continence device have 
not been observed.
    FDA does not believe there is sufficient information to eliminate 
fumed amorphous silica as a potential risk to health associated with 
the implanted mechanical/hydraulic urinary continence device, 
particularly since the amount of fumed amorphous silica is varied in 
order to achieve the desired physical characteristics of the device's 
components. Consequently, the agency believes that this potential risk 
to health should be addressed in a PMA or PDP.

I. Silicone Particle Shedding, Silicone Gel Leakage, and Associated 
Migration

    (Comment 9) There was one comment regarding the risk of silicone 
particle shedding. This comment stated that the potential risk to 
patients with implanted mechanical/hydraulic urinary continence devices 
is small, and should be deleted from the list of significant risks.
    Based upon information presented in the comments, FDA agrees that 
silicone particle shedding is not a risk to health of the implanted 
mechanical/hydraulic urinary continence device. Although silicone 
particle shedding and subsequent migration have been reported with 
implanted mechanical/hydraulic urinary continence devices (Ref. 1), the 
quantity of such particles was minimal and no deleterious effects were 
associated with this finding. Furthermore, subsequent research 
published after the proposed call for PMA's and PDP's was unable to 
document evidence of silicone particle migration (Ref. 2). FDA, 
therefore, does not believe silicone particle shedding is a risk that 
needs to be addressed in PMA's or PDP's for these devices.
    (Comment 10) One comment stated that silicone gel leakage and gel 
bleed are not risks to the health associated with this device since 
there are no implanted mechanical/hydraulic urinary continence devices 
that contain silicone gel.
    FDA disagrees with the comment that no implanted mechanical/
hydraulic urinary continence device contains silicone gel. FDA is aware 
of at least one device model, no longer marketed in the United States, 
that contained silicone gel within its silicone elastomer envelope. FDA 
agrees with the comment that the potential risks of silicone gel are 
not applicable to implanted mechanical/hydraulic urinary continence 
devices that do not contain silicone gel.

J. Need for Risk/Benefit Information

    (Comment 11) One comment stated that FDA should justify the need 
for risk/benefit data for various subgroups as is done in the 
literature. The literature lists the medical conditions at high risk 
for surgery (e.g., spinal cord injured patients, and Type I diabetics 
with high levels of glycosylated hemoglobin), as well as subgroups for 
whom less than optimal results may occur. Two comments were received 
regarding the collection of information on the presurgical workup and 
prior failed conservative treatments. Both comments stated that this 
information can be found in the literature, and that there is no need 
for additional studies to evaluate these areas.
    Although some information pertaining to these issues can be found 
in the literature, FDA believes that more comprehensive and complete 
data are needed regarding the risk/benefit analysis for each subgroup 
for whom the device will be indicated.
    (Comment 12) There was one comment objecting to the concern that 
the device may have effects upon male sexual function. This comment 
stated that a majority of the male patients receiving these devices are 
either post-prostatectomy or post-pelvic trauma patients who, 
independent of the device, would be at high risk for developing 
erectile function problems.
    Because not all patients would be at risk of developing erectile 
dysfunction independent of the device, FDA believes that all potential 
risks should be identified and that the frequency of these risks should 
be reported to allow the patient to make an informed choice regarding 
options for treatment.

K. PMA Contents

    (Comment 13) FDA received one extensive comment on the types of 
manufacturing information, pre-clinical testing, and clinical data that 
should be required in a PMA for an implanted mechanical/hydraulic 
urinary continence device, as well as two general comments on the 
appropriate contents of a PMA.
    FDA agrees with many of the points raised in these comments. 
Although the 1995 guidance document describes the general types of 
manufacturing, pre-clinical, and clinical data that FDA believes can 
support approval of a PMA for an implanted mechanical/hydraulic urinary 
continence device, the agency realizes that other, scientifically sound 
methods exist for addressing the identified risks and benefits of the 
device and encourages manufacturers to document the safety and 
effectiveness of their device using least burdensome approaches. In 
fact, FDA has agreed to the use of many of these alternative approaches 
for the collection and analysis of data in its past interactions with 
manufacturers of implanted mechanical/hydraulic urinary continence 
devices. Furthermore, FDA intends to revise the 1995 guidance document 
to incorporate many of these comments.

III. Findings With Respect to Risks and Benefits

A. Degree of Risk

1. Erosion
    Erosion is the breakdown of tissue adjacent to the device. Types of 
erosion, which have been reported, include: cuff erosion into the 
urethra or bladder neck and pump erosion through the labia, vagina, 
scrotum and the perineum. Factors contributing to erosion include 
infection of the prosthesis, previous surgery, poor vascularization, 
prior pelvic irradiation, improper cuff size, improper reservoir 
volume, surgical injury, excessive urethral compression, and premature 
activation. Erosion may lead to device extrusion, and can require 
surgical intervention.
2. Infection
    Infection is a risk associated with any surgical implant procedure, 
including the implanted mechanical/hydraulic urinary continence device. 
Compromised device sterility and surgical techniques may be a major 
contributing factor to this risk. Infection may result in the removal 
of the implant and may result in an inability to replace the device.
3. Mechanical Malfunctions
    As with other prosthetic devices intended to restore a physiologic 
function, implanted mechanical/hydraulic urinary continence devices may 
mechanically malfunction. Reported types of mechanical malfunctions 
include leakage, tubing kinks, disconnection of tube, pump

[[Page 57730]]

assembly failure, and balloon herniation. Mechanical malfunctions may 
be caused by improper device handling or improper surgical technique, 
or problems with the device's design or manufacturing process. Surgical 
intervention to remove or replace the device is required if the patient 
desires a functional prosthesis or if the device malfunction results in 
total urinary retention.
4. Iatrogenic Disorders
    Improper device handling, inadequate pressure within the system, 
and device missizing are among the preventable complications caused as 
a result of surgical technique. Iatrogenic disorders may be responsible 
for various adverse conditions necessitating device removal and/or 
replacement.
5. Hydronephrosis
    This complication has mostly occurred when the device is implanted 
in patients with nerve or spinal cord damage. The pathogenesis and 
incidence of this risk is unknown.
6. Human Carcinogenicity
    The potential for developing cancer as a result of the long-term 
implantation of the implanted mechanical/hydraulic urinary continence 
device cannot be eliminated as a potential risk associated with this 
device.
7. Human Reproductive and Teratogenic Effects
    Although FDA is not aware of data indicating that the implanted 
mechanical/hydraulic urinary continence device is associated with 
reproductive and teratogenic effects, the potential for teratogenicity 
and other reproductive adverse effects as a result of long-term 
implantation of the device cannot be eliminated as a possible risk to 
health.
8. Immune Related Connective Tissue Disorders--Immunological 
Sensitization
    The potential for developing immunological effects and/or 
connective tissue disorders as a result of long-term exposure to the 
implanted mechanical/hydraulic urinary continence device remains 
uncertain. Since the publication of the proposed rule 5 years ago, new 
epidemiological data (Refs. 3, 4 and 5) addressing the relationship 
between silicone breast prostheses and autoimmune diseases or 
connective tissue diseases indicate that silicone breast prostheses 
have not caused a large increase in the incidence of connective tissue 
disease in women with breast implants. However, the possibility of a 
smaller, increased risk of immunological effects among people with 
implanted mechanical/hydraulic urinary continence devices, or of an 
atypical, as yet undefined, syndrome or disease, cannot be eliminated 
based on these data.
9. Biological Effects of Silica
    Amorphous fumed silica is bound to the silicone in the elastomer of 
the implanted mechanical/hydraulic urinary continence device. Silica 
presents a potential risk which should be addressed in a PMA or PDP.
10. Silicone Gel Leakage and Associated Migration
    Small quantities of silicone gel are present in at least one model 
of the implanted mechanical/hydraulic urinary continence device. 
Silicone gel leakage and associated migration are potential risks, 
which should be addressed in a PMA or PDP for any device that contains 
this material.
11. Degradation of Polyurethane Elastomer
    Polyurethane elastomer materials, which may be present in some 
implanted mechanical/hydraulic urinary continence devices, may degrade 
over time and release degradation products which are potential 
carcinogens in animals. When present, polyurethane elastomer 
degradation is a potential risk which should be addressed in a PMA or 
PDP.
12. Degradation of Polyurethane Foam
    Polyurethane foam materials, which may be present in some implanted 
mechanical/hydraulic urinary continence devices, are known to degrade 
over time. When present, polyurethane foam degradation is a potential 
risk which should be addressed in a PMA or PDP.
13. Other Reported Complications
    Other reported complications associated with the implantation of 
the implanted mechanical/hydraulic urinary continence device include 
perineal discomfort/pain, development of bladder hyperreflexia, 
worsening/persistence of incontinence, urinary retention, hematoma, 
inguinal hernia formation, fibrous capsule formation, failure of cuff 
to deflate, broken tubing, fistula formation from urethral erosion, 
urethral scarring, bleeding, urethral stricture requiring urethrotomy, 
wound dehiscence, pelvic abscess, and fistula to the skin. These 
complications should be addressed in a PMA or PDP.

B. Benefits of the Device

    The implanted mechanical/hydraulic urinary continence device is 
intended to restore urinary continence. It has the potential to be an 
effective treatment for urinary incontinence. Implant recipients may 
also benefit from an improved quality of life and self-esteem.

IV. Final Rule

    Under section 515(b)(3) of the act, FDA is adopting the findings as 
published in the preamble to the proposed rule and is issuing this 
final rule to require premarket approval of the generic type of device, 
the implanted mechanical/hydraulic urinary continence device, by 
revising Sec. 876.5280(c).
    Under the final rule, a PMA or a notice of completion of a PDP is 
required to be filed on or before December 26, 2000, for any implanted 
mechanical/hydraulic urinary continence device that was in commercial 
distribution before May 28, 1976, or that has been found by FDA to be 
substantially equivalent to such a device on or before December 26, 
2000. An approved PMA or a declared completed PDP is required to be in 
effect for any such device on or before 180 days after FDA files the 
application. Any other implanted mechanical/hydraulic urinary 
continence device that was not in commercial distribution before May 
28, 1976, or that has not been found by FDA to be substantially 
equivalent to such a device on or before December 26, 2000, is required 
to have an approved PMA or a declared completed PDP in effect before it 
may be marketed.
    If a PMA or a notice of completion of a PDP for an implanted 
mechanical/hydraulic urinary continence device is not filed on or 
before December 26, 2000, that device will be deemed adulterated under 
section 501(f)(1)(A) of the act, and commercial distribution of the 
device will be required to cease immediately. The device may, however, 
be distributed for investigational use, if the requirements of the 
investigational device exemption (IDE) regulations (part 812) (21 CFR 
part 812) are met.
    Under Sec. 812.2(d) of the IDE regulations, FDA hereby stipulates 
that, on the effective date of this rule, the exemptions from the IDE 
requirements in Sec. 812.2(c)(1) and (c)(2) will no longer apply to 
clinical investigations of the implanted mechanical/hydraulic urinary 
continence device. Further, FDA concludes that investigational 
implanted mechanical/hydraulic urinary continence devices are 
significant risk devices as defined in

[[Page 57731]]

Sec. 812.3(m) and advises that, as of the effective date of this rule, 
the requirements of the IDE regulations regarding significant risk 
devices will apply to any clinical investigation of an implanted 
mechanical/hydraulic urinary continence device. For any implanted 
mechanical/hydraulic urinary continence device that is not the subject 
of a timely filed PMA or PDP, an IDE must be in effect under 
Sec. 812.20 on or before 90 days after the effective date of this 
regulation or distribution of the device must cease. FDA advises all 
persons presently sponsoring a clinical investigation involving the 
implanted mechanical/hydraulic urinary continence device to submit an 
IDE application to FDA no later than 60 days after the effective date 
of this final rule to avoid the interruption of ongoing investigations.

V. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) 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.

VI. Analysis of Impacts

    FDA has examined the impacts of the final 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 Enforcement 
Fairness Act of 1996 (Public Law 104-121), and the Unfunded Mandates 
Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs 
agencies to assess all costs and benefits of available regulatory 
alternatives and, when regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health and safety, and other advantages; 
distributive impacts; and equity). The agency believes that this final 
rule is consistent with the regulatory philosophy and principles 
identified in the Executive Order. In addition, the final rule is not a 
significant regulatory action as defined by the Executive Order and so 
is not subject to review under the Executive Order.
    FDA expects that only one or two manufacturers will submit a PMA or 
PDP for the implanted mechanical/hydraulic urinary continence device. 
FDA estimates that it costs up to $1 million to develop and submit a 
PMA or PDP for this type of device. As noted previously, the implanted 
mechanical/hydraulic urinary continence device was classified into 
class III on November 23, 1983, and FDA published a proposed rule to 
require a PMA or PDP for this device on February 15, 1995. Thus, 
manufacturers have long been aware of the need to develop information 
in support of a PMA or a PDP. The cost of developing the data, 
therefore, has been spread over the past several years. Moreover, since 
the publication of the proposed rule, FDA has been working closely with 
the manufacturers to assist them in preparing for the submission of a 
PMA or a PDP. FDA, therefore, believes that this final rule will not be 
an undue burden on these manufacturers.
    Because only one or two companies will incur costs, the agency 
therefore certifies that the final rule will not have a significant 
economic impact on a substantial number of small entities. Therefore, 
under the Regulatory Flexibility Act, no further analysis is required.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public 
Law 104-4) requires that agencies prepare a written statement of 
anticipated costs and benefits before proposing any rule that may 
result in an expenditure by State, local, and tribal governments, in 
the aggregate, or by the private sector, of $100 million in any one 
year (adjusted annually for inflation). The Unfunded Mandates Reform 
Act does not require FDA to prepare a statement of costs and benefits 
for the proposed rule, because the proposed rule is not expected to 
result in any 1-year expenditure that would exceed $100 million.

VII. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by OMB under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3530). The burden hours required for '876.5280(c) are 
reported and approved under OMB Control No. 0910-0231.

VIII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the order and, consequently, a federalism 
summary impact statement is not required.

IX. References

    The following references have been placed on display in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. These references may be seen in 
the office above between 9 a.m. and 4 p.m., Monday through Friday.
    1. Barrett, D. M., D. C. O'Sullivan, A. A. Maliza, 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.
    2. 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.
    3. Hennekens, C. H., I. Lee, N. Cook, P. R. Hebert, E. W. Karlson, 
F. LaMotte, J. E. Manson, and J. E. Buring, ``Self-reported Breast 
Implants and Connective-Tissue Diseases in Female Health 
Professionals,''Journal of the American Medical Association, 275:616-
621, 1996.
    4. Silverman, B. G., S. L. Brown, R. A. Bright, R. G. Kaczmarek, J. 
B. Arrowsmith-Lowe, and D. A. Kessler, ``Reported Complications of 
Silicone Gel Breast Implants: An Epidemiologic Review,''Annals of 
Internal Medicine, 124:744-756, 1996.
    5. Institute of Medicine, ``Safety of Silicone Breast Implants,'' 
National Academy Press, Washington, DC, 1999.

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, 21 CFR part 
876 is amended as follows:

PART 876--GASTROENTEROLOGY AND 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 876.5280 is amended by revising paragraph (c) to read as 
follows:


Sec. 876.5280  Implanted mechanical/hydraulic urinary continence 
device.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December

[[Page 57732]]

26, 2000, for any implanted mechanical/hydraulic urinary continence 
device that was in commercial distribution before May 28, 1976, or that 
has, on or before December 26, 2000, been found to be substantially 
equivalent to an implanted mechanical/hydraulic urinary continence 
device that was in commercial distribution before May 28, 1976. Any 
other implanted mechanical/hydraulic urinary continence device shall 
have an approved PMA or a declared completed PDP in effect before being 
placed in commercial distribution.

    Dated: September 11, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-24632 Filed 9-25-00; 8:45 am]
BILLING CODE 4160-01-F