[Federal Register Volume 62, Number 117 (Wednesday, June 18, 1997)]
[Proposed Rules]
[Pages 33044-33046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15993]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 868, 884, and 890

[Docket No. 94N-0418]


Retaining Certain Preamendment Class III Devices in Class III

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to retain 
the following preamendment class III devices in class III: Lung water 
monitor, powered vaginal muscle stimulator for therapeutic use, and 
stair-climbing wheelchair. Manufacturers of these referenced 
preamendment class III devices were requested, by an order published in 
the Federal Register, to submit a summary of, and a citation to, all 
information known or otherwise available to them respecting their 
devices, including adverse safety or effectiveness information 
concerning the devices that had not been submitted under the Federal 
Food, Drug, and Cosmetic Act (the act). FDA believes that these devices 
should remain in class III because insufficient information exists to 
determine that special controls would provide reasonable assurance of 
their safety and effectiveness, and/or these devices present a 
potential unreasonable risk of illness or injury.
DATES: Submit written comments by September 16, 1997. FDA proposes that 
any final rule that may issue based on this proposal become effective 
30 days after the date of publication of the final rule.

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: Lisa A. Rooney, Center for Devices and 
Radiological Health (HFZ-403), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1190.

SUPPLEMENTARY INFORMATION:

I. Background

    The act (21 U.S.C. 321 et seq.), as amended by the Medical Device 
Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295) and the Safe 
Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-629), established a 
comprehensive system for the regulation of medical devices intended for 
human

[[Page 33045]]

use. Section 513 of the act (21 U.S.C. 360c) established three classes 
of devices, depending on the regulatory controls needed to provide 
reasonable assurance of their safety and effectiveness. The three 
classes of devices are class I (general controls), class II (special 
controls), and class III (premarket approval). Generally, devices that 
were in commercial distribution before May 28, 1976 (the date of 
enactment of the 1976 amendments), and devices marketed on or after 
that date that are substantially equivalent to such devices, have been 
classified by FDA. This proposed rule refers to both the devices that 
were in commercial distribution before May 28, 1976, and the 
substantially equivalent devices that were in commercial distribution 
on or after that date, as ``preamendment devices.''
    The SMDA added new section 515(i) (21 U.S.C. 360e(i)) to the act. 
This section requires FDA to order manufacturers of preamendment class 
III devices, for which no final regulation has been issued requiring 
the submission of premarket approval applications (PMA's), 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 that has not been submitted under 
section 519 of the act (21 U.S.C. 360i) (hereinafter referred to as 
``515(i) orders).'' Section 519 of the act requires manufacturers, 
importers, and distributors to maintain records and to report 
information that reasonably suggests that one of its marketed devices 
may have caused or contributed to a death or serious injury, or that a 
malfunction of the device is likely to cause death or serious injury on 
recurrence. Section 515(i)(2) of the act directs FDA to publish 
proposed and final regulations when devices, subject to 515(i) orders, 
are to remain in class III or be reclassified into class I or class II. 
Section 515(i)(3) of the act directs FDA to establish a schedule for 
the issuance of rules requiring the submission of PMA's for devices 
remaining in class III.
    Accordingly, in the Federal Register of August 14, 1995 (60 FR 
41984), FDA issued an order under section 515(i) of the act requiring 
manufacturers of 27 preamendment class III devices to submit to FDA a 
summary of, and citation to, all information known or otherwise 
available to them respecting such devices, including adverse safety or 
effectiveness information concerning the devices that had not been 
submitted under section 519 of the act. FDA requested this information 
in order to determine, for each device, whether the classification of 
the device should be revised, or whether a regulation requiring the 
submission of PMA's for the device should be issued.
    Based on the lack of safety and effectiveness information submitted 
in response to the section 515(i) order, FDA proposes that the devices 
discussed in sections I.A., B., and C of this document remain in class 
III because, for each of these devices: (1) Insufficient information 
exists to determine that general controls alone, or that general 
controls together with special controls, would provide reasonable 
assurance of the device's safety and effectiveness, and/or (2) these 
devices present a potential unreasonable risk of illness or injury.

A. Lung Water Monitor (21 CFR 868.2450)

    In the Federal Register of November 2, 1979 (44 FR 63292 at 63341), 
FDA proposed to classify the lung water monitor into class III, in 
accordance with the recommendation of the Anesthesiology Device 
Classification Panel (the Panel). The lung water monitor is intended to 
monitor the trend of fluid volume changes in a patient's lung by 
measuring changes in thoracic electrical impedance by means of 
electrodes placed on the patient's chest. The Panel recommended 
classifying this device into class III because the Panel believed that 
the lung water monitor presented a potential unreasonable risk of 
illness or injury. The Panel also believed that insufficient 
information existed to determine whether performance standards would be 
adequate to provide reasonable assurance of the safety and 
effectiveness of the device. In accordance with the Panel's 
recommendation, FDA issued a final rule in the Federal Register of July 
16, 1982 (47 FR 31130 at 31142) classifying the lung water monitor into 
class III.
    The safety risks associated with the lung water monitor using a 
double indicator dilution technique include: (1) Typical risks 
associated with the placement of a catheter, such as thrombosis and 
hematomas; (2) electrical shock; (3) misdiagnosis if the device is not 
calibrated or does not accurately measure changes in lung fluid volume; 
and (4) inappropriate therapy. The safety risks associated with the 
lung water monitor using thoracic impedance include: (1) Electrical 
shock; (2) misdiagnosis; and (3) inappropriate therapy.
    The Panel's original concerns regarding the clinical effectiveness 
of the technology have not been resolved. The literature that has been 
published has not produced clear results regarding the effectiveness of 
this device; it does suggest, however, that this device may have some 
potential use in certain specific diseases. Unfortunately, this 
information is based on the results of a lung water computer device 
that is no longer marketed. Alternative technology, such as pulmonary 
artery catheterization, chest x-ray, and echocardiography are now in 
common use for evaluation of congestive heart failure or pulmonary 
edema. Because insufficient information, i.e. lack of information 
regarding the technology, particularly the effectiveness of the 
technology, exists to determine either that general controls alone, or 
that general controls together with special controls would provide 
reasonable assurance of the device's safety and effectiveness, FDA 
proposes that the device remain in class III.
    Furthermore, FDA concludes that this device continues to present 
the same potential unreasonable risk of illness or injury that was 
first identified by the original classification panel because the 
agency has not received any additional information regarding the safety 
and effectiveness of this device. FDA, therefore, proposes that this 
device remain in class III.

B. Powered Vaginal Muscle Stimulator for Therapeutic Use (21 CFR 
884.5940)

    In the Federal Register of April 3, 1979 (44 FR 19894 at 19969), 
FDA proposed to classify into class III, in accordance with the 
recommendation of the Obstetrical and Gynecological Device 
Classification Panel (the Ob/Gyn Panel), the powered vaginal muscle 
stimulator for therapeutic use intended to increase muscle tone and 
strength in the treatment of sexual dysfunction. The Ob/Gyn Panel 
recommended classifying this device into class III because the Ob/Gyn 
Panel believed that the satisfactory performance of the device had not 
been demonstrated. The Ob/Gyn Panel also questioned the usefulness of 
this device when used in the treatment of sexual dysfunction. In fact, 
only one citation in the clinical literature was referenced in FDA's 
proposed rule classifying the device and that one reference indicated 
that vaginal muscle stimulation in the treatment of sexual dysfunction 
had fallen into disuse. In accordance with the Ob/Gyn Panel's 
recommendation, FDA issued a final rule in the Federal Register of 
February 26, 1980 (45 FR 12684) classifying the powered vaginal muscle 
stimulator for therapeutic use into class III.
    The safety risks associated with the powered vaginal muscle 
stimulator for

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therapeutic use intended to increase muscle tone and strength in the 
treatment of sexual dysfunction include: (1) Electrical shock; (2) 
burns; (3) irritation, trauma, hemorrhage, and perforation; and (4) 
adverse tissue reaction.
    FDA is unaware of any manufacturers who currently market powered 
vaginal muscle stimulators for treatment of sexual dysfunction. Only 
one manufacturer of this device was ever registered. That one 
manufacturer, however, is no longer registered. Moreover, no 
manufacturers responded to the 515(i) order requesting the submission 
of information and announcing FDA's intention to keep this device in 
class III.
    In the absence of information from manufacturers, FDA conducted a 
thorough search of the medical literature, including clinical texts, on 
the treatment of sexual dysfunction using powered vaginal muscle 
stimulation. No references were identified by this search. In addition, 
review of the available information on this device shows that there is 
no evidence in the literature demonstrating the effectiveness of this 
device for the treatment of sexual dysfunction. As a result, FDA 
proposes that the powered vaginal muscle stimulator intended for the 
treatment of sexual dysfunction remain in class III because 
insufficient information exists to determine either that general 
controls alone or that general controls together with special controls 
would provide reasonable assurance of the device's safety and 
effectiveness.
    Moreover, because FDA has not received any additional information 
regarding the safety and effectiveness of this device in response to 
the 515(i) order, FDA concludes that this device continues to present 
the same potential unreasonable risks of illness or injury that were 
first identified by the original classification panel. FDA, therefore, 
proposes that this device remain in class III.

C. Stair-Climbing Wheelchair (21 CFR 890.3890)

    In the Federal Register of August 28, 1979 (44 FR 50497), FDA 
proposed to classify into class III, in accordance with the 
recommendation of the Physical Medicine Device Classification Panel 
(the Physical Medicine Panel), the stair-climbing wheelchair intended 
for medical purposes to provide mobility to persons restricted to a 
sitting position. The device is intended to climb stairs by means of 
two endless belt tracks that are lowered from under the chair and 
adjusted to the angle of the stairs. The Physical Medicine Panel 
recommended classifying this device into class III because it believed 
that satisfactory performance of the device had not been demonstrated, 
and, therefore, it is not possible to establish an adequate performance 
standard for the device. The Physical Medicine Panel also noted that 
the device was experimental, and data to support its safe and effective 
use were not available. Subsequently, in the Federal Register of 
November 23, 1983 (48 FR 53032 at 53047), FDA issued a final rule 
classifying into class III the stair-climbing wheelchair, in accordance 
with the recommendation of the Physical Medicine Panel.
    The safety risks associated with the stair-climbing wheelchair 
include bodily injury. If the device fails the disabled patient could 
fall and be seriously or fatally injured.
    To date, the agency has not received any information in response to 
the 515(i) order. Because the agency has not received any additional 
information regarding the safety and effectiveness of this device, FDA 
concludes that the satisfactory performance of the device still remains 
to be demonstrated. It is still not possible to establish adequate 
special controls for the device. Therefore, FDA proposes that the 
stair-climbing wheelchair remain in class III.
    Furthermore, FDA concludes that this device continues to present 
the same potential unreasonable risks of illness or injury that were 
first identified by the original classification panel because the 
agency has not received any additional information regarding the safety 
and effectiveness of this device. Insufficient information exists to 
determine either that general controls alone or that general controls 
together with special controls would provide reasonable assurance of 
the safety and effectiveness of this device. FDA, therefore, proposes 
that this device remain in class III.

II. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(8) 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.

III. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
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. Because this proposal simply retains class III 
devices in class III, the agency certifies that the proposed 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.

IV. Congressional Review

    This rule is not a major rule under the congressional review 
provisions of Subtitle E of the Small Business Regulatory Enforcement 
Fairness Act of 1996 (Pub. L. 104-121).

V. Comments

    Interested persons may, on or before September 16, 1997 submit to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 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.
    This proposed rule is issued under sections 513, 515(i), and 701(a) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c, 360e(i), 
and 701(a)) and under authority of the Commissioner of Food and Drugs.

    Dated: June 4, 1997.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 97-15993 Filed 6-17-97; 8:45 am]
BILLING CODE 4160-01-F