[Federal Register: June 12, 2002 (Volume 67, Number 113)]
[&thnsp;Notices]               
[Page 40318]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jn02-92]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D–0228]

 
Medical Devices; Implantable Middle Ear Hearing Device; Draft 
Guidance for Industry and FDA; Availability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availability of the draft guidance entitled “Implantable Middle 
Ear Hearing Device; Draft Guidance for Industry and FDA.” This 
guidance document represents the agency's current thinking on the 
technical content and clinical considerations for a premarket approval 
application (PMA) for an implantable middle ear hearing device (IMEHD). 
This guidance provides information to consider for developing the 
clinical studies and generating the scientific evidence that will 
provide reasonable assurance of safety and effectiveness of the IMEHD 
for its intended use. This draft guidance is neither final nor is it in 
effect at this time.

DATES: Submit written or electronic comments on the guidance by 
September 10, 2002.

ADDRESSES: Submit written requests for single copies on a 3.5″ 
diskette of the guidance document entitled “Implantable Middle 
Ear Hearing Device; Draft Guidance for Industry and FDA” to the 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. 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. Identify comments with the docket 
number found in brackets in the heading of this document. 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, ext. 
187.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance describes the kind of information needed to 
allow FDA to evaluate the safety and effectiveness of an IMEHD. It is 
based in part upon current scientific knowledge, current FDA review 
criteria, and discussions and recommendations resulting from an Ear 
Nose and Throat Devices Advisory Panel Meeting that was held on June 
18, 1999.

II. Significance of Guidance

    This draft 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 IMEHD. 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 statutes and regulations.

III. Electronic Access

    In order to receive the “Implantable Middle Ear Hearing 
Device; Draft 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 (1406) 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 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 Internet site may be accessed at 
http://www.fda.gov/cdrh. A search capability for all CDRH guidance 
documents is available 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 the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the draft guidance by 
September 10, 2002. 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 are available 
for public examination in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: May 31, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02–14839 Filed 6–11–02; 8:45 am]
BILLING CODE 4160–01–S