[Federal Register: November 8, 2005 (Volume 70, Number 215)]
[Notices]
[Page 67724-67725]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08no05-44]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0344]
Draft Guidance for Industry and Food and Drug Administration
Staff; Class II Special Controls Guidance Document: Tinnitus Masker
Devices; 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availability of the draft guidance entitled ``Class II Special Controls
Guidance Document: Tinnitus Masker Devices.'' The draft guidance
describes a means by which tinnitus masker devices may comply with the
requirement of special controls for class II devices. Elsewhere in this
issue of the Federal Register, FDA is publishing a proposed rule to
amend the classification regulations for the tinnitus masker presently
classified into class II (special controls: labeling) to designate a
special control for these devices. The draft guidance is neither final,
nor is it in effect at this time.
DATES: Submit written or electronic comments on this draft guidance by
February 6, 2006.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the draft guidance document entitled ``Class II Special
Controls Guidance Document: Tinnitus Masker Devices'' 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 one self-
addressed adhesive label 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INFORMATION section for information on electronic access to the draft
guidance.
Submit written comments concerning this draft guidance to the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.
FOR FURTHER INFORMATION CONTACT: Teresa Cygnarowicz, Center for Devices
and Radiological Health (HFZ-460), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2980.
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal Register, FDA is publishing
a proposed rule to amend the classification regulations for tinnitus
masker devices presently classified into class II (special controls:
labeling) to designate a special control for the devices. The draft
guidance document describes a means by which the device may comply with
the requirement of special controls for class II devices. Following the
effective date of a final rule based on the proposed rule, any firm
submitting a 510(k) premarket notification for the device will need to
address the issues covered in the special control guidance. However,
the firm need only show that its device meets the recommendations of
the guidance or in some other way provides equivalent assurances of
safety and effectiveness.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on tinnitus
masker devices. 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 an approach satisfies the requirements of
the applicable statute and regulations.
III. Electronic Access
To receive ``Class II Special Controls Guidance Document: Tinnitus
Masker Devices'' by fax, 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 (1555) 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 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 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 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 draft guidance contains information collection provisions that
are subject to 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 draft guidance
document have been approved by OMB in accordance with the PRA under the
regulations governing premarket notification submissions (21 CFR part
807, subpart E), under OMB control number 0910-0120. The labeling
provisions addressed in the draft guidance have been approved by OMB
under OMB control number 0910-0485.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic
[[Page 67725]]
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: October 7, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-22268 Filed 11-7-05; 8:45 am]
BILLING CODE 4160-01-S