[Federal Register Volume 66, Number 158 (Wednesday, August 15, 2001)]
[Notices]
[Pages 42870-42871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20572]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0311]


Medical Devices: Draft Guidance on ``Class II Special Control 
Guidance Document: Endolymphatic Shunt Tube With Valve; Draft Guidance 
for Industry and FDA;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Class II Special Control 
Guidance Document: Endolymphatic Shunt Tube With Valve; Draft Guidance 
for Industry and FDA.'' This draft guidance document will serve as the 
special control for reclassification of the endolymphatic shunt tube 
with valve device from class III to class II. The draft guidance 
document outlines the technical areas to address in order to control 
the risks associated with the endolymphatic shunt tube with valve and 
to provide for a timely premarket notification (510(k)) review. This 
draft guidance is neither final nor is it in effect at this time.

DATES: Submit written or electronic comments on the draft guidance by 
November 13, 2001.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the draft guidance entitled ``Class II Special Control Guidance 
Document: Endolymphatic Shunt Tube With Valve; Draft Guidance for 
Industry and FDA'' to the Division of Small Manufacturers Assistance 
(HFZ-220), Center for Devices and Radiological Health (CDRH), Food and 
Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two 
self-addressed adhesive labels to assist that office in processing you 
request, or fax your request to 301-443-8818. Submit written comments 
concerning this draft guidance to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: James K. Kane, 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

    FDA is announcing the availability of a draft guidance entitled 
``Class II Special Control Guidance Document: Endolymphatic Shunt Tube 
With Valve; Draft Guidance for Industry and FDA.'' The draft guidance 
document is the special control guidance for the endolymphatic shunt 
tube with valve. Elsewhere in this issue of the Federal Register, FDA 
is proposing to reclassify the device from class III to class II when 
it is intended to be implanted in the inner ear to relieve the symptoms 
of vertigo and hearing loss due to endolymphatic hydrops of Meniere's 
Disease. FDA intends that this draft guidance document, if finalized, 
will serve as the special control for the endolymphatic shunt tube with 
valve. If finalized, the guidance will supersede the guidance document 
entitled ``Guidance for the Technical Content of a Premarket Approval 
Application for an Endolymphatic Shunt Tube With Valve'' that FDA 
issued in April 1990.

II. Significance of Guidance

    The draft guidance represents the agency's current thinking on the 
endolymphatic shunt tube with valve. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the applicable statutes and regulations.
    The agency has adopted good guidance practices (GGPs), and 
published the final rule, which set forth the agency's regulations for 
the development, issuance, and use of guidance documents (21 CFR 
10.115). This draft guidance document is issued as a level 1 guidance 
in accordance with the GGP regulations.

III. Electronic Access

    In order to receive ``Class II Special Control Guidance Document: 
Endolymphatic Shunt Tube With Valve; Draft Guidance for Industry and 
FDA'' via your fax machine, call the CDRH

[[Page 42871]]

Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch 
tone telephone. Press 1 to enter the system. At the second voice prompt 
press 1 to order a document. Enter document number 791 followed by the 
pound sign (#). Follow the remaining voice prompts to complete your 
request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so using the Internet. CDRH maintains an entry on the Internet 
for easy access to information including text, graphics, and files that 
may be downloaded to a personal computer with Internet access. Updated 
on a regular basis, the CDRH home page includes the civil money penalty 
guidance documents package, device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh. Guidance documents are also available on the Dockets Management 
Branch Web site at http://www.fda.gov/ohrms/dockets/default.htm.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments on the draft guidance by 
November 13, 2001. 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. The draft guidance and received comments may be seen in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: August 2, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 01-20572 Filed 8-14-01; 8:45 am]
BILLING CODE 4160-01-S