[Federal Register Volume 63, Number 125 (Tuesday, June 30, 1998)]
[Rules and Regulations]
[Pages 35516-35517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17290]


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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]


Medical Devices; Retention of Three Preamendment Class III 
Devices in Class III

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is retaining the 
following three preamendments class III devices in class III: Lung 
water monitor, powered vaginal muscle stimulator for therapeutic use, 
and stair-climbing wheelchair. The agency is taking this action 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.

EFFECTIVE DATE: July 30, 1998.

FOR FURTHER INFORMATION CONTACT: Janet L. Scudiero, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1184.
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 18, 1997 (62 FR 33044), FDA issued 
a proposed rule to retain the lung water monitor, the powered vaginal 
muscle stimulator for therapeutic use, and the stair-climbing 
wheelchair in class III. This proposed retention in class III was based 
on a lack of information submitted in response to the section 515(i) of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(i)) 
order to determine whether or not special controls could be established 
to reasonably assure the safety and effectiveness of these devices.
    Interested persons were given until September 16, 1997, to comment 
on the proposed rule. During the comment period, FDA received no 
comments on the proposed rule.

II. FDA's Conclusion

    FDA has concluded that insufficient information exists to establish 
special controls to provide reasonable assurance of the safety and 
effectiveness of the lung water monitor, the powered vaginal muscle 
stimulator for therapeutic use, and the stair-climbing wheelchair and/
or that these devices present a potential unreasonable risk of illness 
or injury.

III. 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.

[[Page 35517]]

IV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354), as 
amended by subtitle D of the Small Business 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 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.
    If a rule has a significant economic impact on a substantial number 
of small entities, the Regulatory Flexibility Act requires agencies to 
analyze regulatory options that would minimize any significant impact 
of a rule on small entities. Because FDA believes that there is little 
or no interest in marketing these devices, and because this rule 
retains these devices as previously classified, the agency certifies 
that this final rule will not have a significant impact on a 
substantial number of small entities. Therefore, under the Regulatory 
Flexibility Act, no further analysis is required.

V. Paperwork Reduction Act of 1995

    This rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.
    This final rule is issued under sections 513, 515(i), and 701(a) of 
the act (21 U.S.C. 360c, 360e(i), and 371(a)) and under authority of 
the Commissioner of Food and Drugs.

    Dated: June 17, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-17290 Filed 6-29-98; 8:45 am]
BILLING CODE 4160-01-F