[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
