[Federal Register Volume 67, Number 216 (Thursday, November 7, 2002)]
[Notices]
[Pages 67859-67860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28399]


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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://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://www.fda.gov/cdrh. You may search for all CDRH guidance 
documents 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.

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