[Federal Register: November 7, 2002 (Volume 67, Number 216)]
[Notices]
[Page 67859-67860]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07no02-51]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02D-0439]
Medical Devices; Class II Special Controls Guidance Document:
Transcutaneous Air Conduction Hearing Aid System; 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 guidance entitled ``Class II Special Controls
Guidance Document: Transcutaneous Air Conduction Hearing Aid System;
Guidance for Industry and FDA.'' This document describes a means by
which transcutaneous air conduction hearing aid systems (TACHAS) may
comply with the requirement of special controls for class II devices.
Elsewhere in this issue of the Federal Register, FDA is publishing a
final rule classifying TACHAS into class II (special controls).
DATES: Submit written or electronic comments on this guidance by
February 5, 2003.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``Class II Special Controls
Guidance Document: Transcutaneous Air Conduction Hearing Aid System;
Guidance for Industry and FDA'' to the Division of Small Manufacturers,
International, and Consumer Assistance (HFZ-220), Center for Devices
and Radiological Health, Food and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to
assist that office in processing your request, or fax your request to
301-443-8818. See the SUPPLEMENTARY INFORMATION section for information
on electronic access to the guidance.
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. Comments should be identified with
the docket number found in brackets in the heading of this document.
Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Eric M. 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
The TACHAS is intended to compensate for impaired hearing without
occluding the ear canal. It consists of an air conduction hearing aid
attached to a surgically fitted tube system, which is placed through
the soft tissues between the post auricular region and the outer ear
canal. This special control guidance document lists the risks to health
identified by FDA and describes measures that, if followed by
manufacturers and combined with the general controls, will generally
address the risks associated with these devices.
Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule classifying TACHAS into class II (special controls) under
section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360c(f)(2)). This guidance document will serve as the
special control for the TACHAS device. Section 513(f)(2) of the act
provides that any person who submits a premarket notification under
section 510(k) of the act (21 U.S.C. 360(k)) for a device that has not
previously been classified may,
[[Page 67860]]
within 30 days after receiving an order classifying the device in class
III under section 513(f)(1) of the act, request FDA to classify the
device under the criteria set forth in section 513(a)(1) of the act.
FDA shall, within 60 days of receiving such a request, classify the
device by written order. This classification shall be the initial
classification of the device. Within 30 days after the issuance of an
order classifying the device, FDA must publish a notice in the Federal
Register announcing such classification. Because of the timeframes
established by section 513(f)(2) of the act, FDA has determined, under
Sec. 10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible to
allow for public participation before issuing this guidance as a final
guidance document. Therefore, FDA is issuing this guidance document as
a level 1 guidance document that is immediately in effect. FDA will
consider any comments that are received in response to this notice to
determine whether to amend the guidance document.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices (GGPs) regulation (Sec. 10.115). The guidance represents the
agency's current thinking on TACHAS. 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. This
guidance document is issued as a level 1 guidance consistent with GGPs.
III. Electronic Access
In order to receive the ``Class II Special Controls Guidance
Document: Transcutaneous Air Conduction Hearing Aid System; Guidance
for Industry and FDA'' via your fax machine, call the CDRH 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 the document number (1414) followed
by the pound sign ([numsign]). Follow the remaining voice prompts to
complete your request.
You may obtain a copy of the guidance from the Internet. CDRH
maintains an entry on the Internet for easy access to information
including text, graphics, and files that you may download 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 device-oriented information. You may access the CDRH home
page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh. You may search for all CDRH guidance
documents at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. Guidance documents
are also available on the Dockets Management Branch Internet site at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.
IV. Comments
Interested persons may submit to Dockets Management Branch (see
ADDRESSES) written comments regarding this immediately in effect
guidance by (see DATES). Two copies of any comments are to be
submitted, except that individuals may submit one copy. Identify
comments with the docket number found in brackets in the heading of
this document. The guidance document and comments received may be seen
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: October 28, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-28399 Filed 11-6-02; 8:45 am]
BILLING CODE 4160-01-S