[Federal Register: April 29, 2002 (Volume 67, Number 82)]
[Notices]
[Page 20979-20980]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ap02-83]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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