[Federal Register Volume 67, Number 82 (Monday, April 29, 2002)]
[Rules and Regulations]
[Pages 20893-20894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-10426]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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