[Federal Register: August 15, 2001 (Volume 66, Number 158)]
[Notices]
[Page 42870-42871]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15au01-78]
-----------------------------------------------------------------------
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Medical Devices: Draft Guidance on ``Class II Special Control
Guidance Document: Endolymphatic Shunt Tube With Valve; Draft Guidance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.
-----------------------------------------------------------------------
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availability of the draft guidance entitled ``Class II Special Control
Guidance Document: Endolymphatic Shunt Tube With Valve; Draft Guidance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 This draft guidance document will serve as the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 The draft guidance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draft guidance is neither final nor is it in effect at this time.
DATES: Submit written or electronic comments on the draft guidance by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of the draft guidance entitled ``Class II Special Control Guidance
Document: Endolymphatic Shunt Tube With Valve; Draft Guidance for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concerning this draft guidance to the Dockets Management Branch (HFA-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information on electronic access to the draft guidance document.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