[Federal Register Volume 67, Number 82 (Monday, April 29, 2002)]
[Notices]
[Pages 20979-20980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-10427]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0311]


Medical Devices: Class II Special Controls Guidance Document: 
Endolymphatic Shunt Tube with Valve; Final Guidance for Industry 
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 guidance entitled ``Class II Special Controls 
Guidance Document: Endolymphatic Shunt Tube with Valve; Guidance for 
Industry and FDA.'' This document describes a means by which the 
endolymphatic shunt tube with valve may comply with the requirement of 
special controls for class II devices. Elsewhere in this issue of 
theFederal Register, FDA is publishing a final rule classifying 
endolymphatic shunt tubes with valve into class II (special controls).

DATES: Submit written or electronic comments on the guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the guidance document entitled ``Class II Special Controls Guidance 
Document: Endolymphatic Shunt Tube with Valve; Guidance for Industry 
and FDA'' to the Division of Small Manufacturers, International, and 
Consumer Assistance (HFZ-220), Center for Devices and Radiological 
Health (CDRH), Food and Drug Administration, 1350 Piccard Dr., 
Rockville, MD 20850. Send two self-addressed labels to assist that 
office in processing your request, or fax your request to 301-443-8818. 
Submit written comments concerning this 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 guidance.

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 endolymphatic shunt tube 
with valve from class III (premarket approval) into class II (special 
controls) based on new information regarding this device. E. Benson 
Hood Laboratories, Inc. (Hood Laboratories), submitted the new 
information in a reclassification petition. FDA also identified the 
document ``Class II Special Controls Guidance Document: Endolymphatic 
Shunt Tube with Valve; Draft 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 draft guidance by 
November 13, 2001. FDA received one comment. The comment, from the 
petitioner, Hood Laboratories, strongly supported the draft guidance as 
the proposed special control.
    FDA has since revised the draft guidance to provide to 
manufacturers the option of submitting an abbreviated 510(k) to further 
reduce regulatory burden.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on ``Class II Special Controls Guidance 
Document: Endolymphatic Shunt Tube with Valve; Guidance for Industry 
and FDA.'' 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 requirements of the 
applicable statute and regulations.

III. Electronic Access

    In order to receive the document ``Class II Special Controls 
Guidance Document: Endolymphatic Shunt Tube with Valve; Guidance for 
Industry and FDA'' via your fax machine, call the CDRH Facts-On-Demand 
system at 800-

[[Page 20980]]

899-0381 or 301-827-0111 from a touch-tone telephone. At the first 
voice prompt, press 1 to access DSMICA Facts, at second voice prompt 
press 2, and then enter the document number (791) followed by the pound 
sign (#). Then follow the remaining voice prompts to complete your 
request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the Internet. CDRH maintains a home page at http://www.fda.gov/cdrh on the Internet for easy access to information that 
may be downloaded to a personal computer. Updated on a regular basis, 
the CDRH home page includes 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 medical device 
oriented information. The CDRH home page also includes the document 
``Class II Special Controls Guidance Document: Endolymphatic Shunt Tube 
with Valve; Guidance for Industry and FDA'' which may be accessed at 
http://www.fda.gov/cdrh/ode/guidance/791.html. A search capability for 
all guidance documents may be found at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Dockets 
Management Branch Internet site at http://www.fda.gov/ohrms/dockets.

    Dated: April 15, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-10427 Filed 4-26-02; 8:45 am]
BILLING CODE 4160-01-S