[Federal Register: August 1, 2003 (Volume 68, Number 148)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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.
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
DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
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
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.
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announced the availability of the draft guidance entitled ``Guidance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
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.
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
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