[Federal Register: April 29, 2002 (Volume 67, Number 82)]
[Rules and Regulations]
[Page 20893-20894]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ap02-8]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 874
[Docket No. 97P-0210]
Medical Devices; Ear, Nose and Throat Devices; Reclassification
of the Endolymphatic Shunt Tube With Valve
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is reclassifying the
endolymphatic shunt tube with valve from class III (premarket approval)
into class II (special controls). The device is intended to be
implanted in the inner ear to relieve the symptoms of vertigo and
hearing loss due to endolymphatic hydrops (increase in endolymphatic
fluid) of Meniere's disease. FDA is also identifying the guidance
document entitled ``Class II Special Controls Guidance Document:
Endolymphatic Shunt Tube With Valve; Guidance for Industry and FDA''
(the guidance) as the special control that the agency believes will
reasonably ensure the safety and effectiveness of the device. This
reclassification is based on new information submitted in a
reclassification petition by E. Benson Hood Laboratories, Inc. (Hood
Laboratories). FDA is taking this action under the Federal Food, Drug,
and Cosmetic Act (the act), as amended by the Medical Device Amendments
of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug
Administration Modernization Act of 1997. Elsewhere in this issue of
the Federal Register, FDA is publishing a notice announcing the
guidance.
DATES: This rule is effective May 29, 2002.
FOR FURTHER INFORMATION CONTACT: Eric Mann, Center for Devices and
Radiological Health (HFZ-460), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2080.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 15, 2001 (66 FR 42809), FDA
published a proposed rule to reclassify the
[[Page 20894]]
endolymphatic shunt tube with valve from class III (premarket approval)
into class II (special controls) based on new information regarding
this device. FDA also identified the document entitled ``Class II
Special Controls Guidance Document: Endolymphatic Shunt Tube With
Valve; Guidance for Industry and FDA'' as the special control capable
of providing reasonable assurance of safety and effectiveness for this
device.
Interested persons were invited to comment on the proposed rule by
November 13, 2001. FDA received one comment. The comment, from the
petitioner, Hood Laboratories, supported the proposed reclassification.
II. FDA's Conclusion
Based on a review of the available information referenced in the
preamble to the proposed rule and placed on file in FDA's Dockets
Management Branch, FDA concludes that the guidance document entitled
``Class II Special Controls Guidance Document: Endolymphatic Shunt Tube
With Valve; Guidance for Industry and FDA,'' in conjunction with
general controls, provides reasonable assurance of the safety and
effectiveness of this device. Elsewhere in this issue of the Federal
Register, FDA is announcing the availability of the guidance document.
III. Environmental Impact
The agency has determined under 21 CFR 25.34(b) 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.
IV. 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 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.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Reclassification of the endolymphatic shunt tube
with valve from class III will relieve all manufacturers of these
devices of the cost of complying with the premarket approval
requirements in section 515 of the act.
FDA believes that Hood Laboratories is the only manufacturer of the
endolymphatic shunt tube with valve and Hood Laboratories states that
they are in compliance with special controls proposed for this device.
Therefore, the special controls will not impose significant new costs
on the affected manufacturer. Because reclassification will reduce
regulatory costs with respect to the endolymphatic shunt tube with
valve, 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 this final rule will not have a significant economic impact on a
substantial number of small entities. In addition, this final rule will
not impose costs of $100 million or more on either the private sector
or State, local, and tribal governments in the aggregate, and therefore
a summary statement of analysis under section 202(a) of the Unfunded
Mandates Reform Act of 1995 is not required.
V. 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 Executive order and, consequently, a
federalism summary impact statement is not required.
VI. Paperwork Reduction Act of 1995
FDA concludes that this final 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.
List of Subjects in 21 CFR Part 874
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
874 is amended as follows:
PART 874--EAR, NOSE, AND THROAT DEVICES
1. The authority citation for 21 CFR part 874 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
2. Section 874.3850 is revised to read as follows:
Sec. 874.3850 Endolymphatic shunt tube with valve.
(a) Identification. An endolymphatic shunt tube with valve is a
device that consists of a pressure-limiting valve associated with a
tube intended to be implanted in the inner ear to relieve symptoms of
vertigo and hearing loss due to endolymphatic hydrops (increase in
endolymphatic fluid) of Meniere's disease.
(b) Classification. Class II (special controls). The special
control for this device is the FDA guidance document ``Class II Special
Controls Guidance Document: Endolymphatic Shunt Tube With Valve;
Guidance for Industry and FDA.''
Dated: April 15, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-10426 Filed 4-26-02; 8:45 am]
BILLING CODE 4160-01-S