[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]
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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.
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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
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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
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28. Oesterling, J. E., ``A Simple Technique for Removal of
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29. Parsons, C. L., P. C. Stein, M. K. Dobke, C. P. Virden, and
D. H. Frank, ``Diagnosis and Therapy of Subclinically Infected
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30. Petrou, S. P., and D. M. Barrett, ``The Use of Penile
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33. Reisner, G. S., ``Experience with Penile Prostheses in 107
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34. Steege, J. F., A. L. Stout, and C. C. Carson, ``Patient
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36. Tawil, E. A., and J. G. Gregory, ``Failure of the Jonas
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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
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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