[Federal Register: August 1, 2003 (Volume 68, Number 148)]
[Notices]               
[Page 45256-45257]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01au03-77]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002D-0228]

 
Medical Devices; Guidance for Industry and FDA Staff; Implantable 
Middle Ear Hearing Device; 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 ``Guidance for Industry and FDA 
Staff; Implantable Middle Ear Hearing Device.'' 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.

DATES: Submit written or electronic comments on this 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 ``Guidance for Industry and 
FDA; Implantable Middle Ear Hearing Device'' 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 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 Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
 Identify comments with the docket number found in 
brackets in the heading of this document. 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

    In the Federal Register of June 12, 2002 (67 FR 40318), FDA 
announced the availability of the draft guidance entitled ``Guidance 
for Industry and FDA; Implantable Middle Ear Hearing Device.'' FDA 
invited interested persons to comment on the draft guidance by 
September 10, 2002. On August 16, 2002, FDA held a meeting of the Ear, 
Nose, and Throat Devices Panel of the Medical Devices Advisory 
Committee to discuss the draft guidance.
    FDA received seven comments. In general, most comments suggested 
various clarifications throughout the document. FDA revised the 
document accordingly. One comment stated that the standard entitled 
``ANSI/IEEE C63.19-2001 American National Standard for Methods of 
Measurement of Compatibility Between Wireless Communications Devices 
and Hearing Aids'' was developed for air conduction hearing aids and 
that the standard requires measurements that have been difficult to 
reproduce in these conventional hearing aids. FDA agrees, however, the 
agency believes that portions of this standard may be useful. 
Therefore, the guidance has been revised to recommend that 
manufacturers use test methods cited in this standard that are 
applicable to their device designs. There were two comments requesting 
a more precise definition for the ``control condition'' in the 
suggested clinical study design for IMEHDs. FDA agrees and will replace 
the term ``state-of-the-art'' with ``appropriately fit conventional air 
conduction hearing aids.'' Another comment suggested that measuring 
aided baseline performance is not necessary as a control condition. FDA 
disagrees. The agency believes that it is important to compare IMEHD 
performance to both appropriately fit conventional air conduction 
hearing aid performance and unaided performance for the benefit of 
clinicians and prospective IMEHD recipients.

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 premarket approval applications for 
IMEHDs. 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

    To receive ``Guidance for Industry and FDA Staff; Implantable 
Middle Ear Hearing Device'' by 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 guidance may also do 
so by 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. 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 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web 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 Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets
.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to

[[Page 45257]]

review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections 
of information addressed in the guidance document have been approved by 
OMB in accordance with the PRA under the regulations governing 
premarket approval applications (21 CFR part 814, OMB control number 
0910-0231). The labeling provisions addressed in the guidance have been 
approved by OMB under the PRA under OMB control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: July 16, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-19622 Filed 7-31-03; 8:45 am]

BILLING CODE 4160-01-S