[Federal Register: November 8, 2005 (Volume 70, Number 215)]
[Proposed Rules]
[Page 67652-67654]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08no05-6]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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[[Page 67652]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 874
[Docket No. 2005N-0346]
Ear, Nose, and Throat Devices; Tinnitus Masker; Designation of
Special Controls
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the classification regulations of tinnitus masker devices in order to
specify a special control for the device. The agency is taking this
action on its own initiative. This action is being taken under the
Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe
Medical Devices Act of 1990 (SMDA), and the Food and Drug
Administration Modernization Act of 1997 (FDAMA). Elsewhere in this
issue of the Federal Register, FDA is publishing a notice of
availability of the draft guidance document that the agency proposes to
use as a special control for the device.
DATES: Submit written or electronic comments on the proposed rule by
February 6, 2006. See section XI of this document for the proposed
effective date of a final rule based on this document.
ADDRESSES: You may submit comments, identified by Docket No. 2005N-
0346, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described in the
Electronic Submissions portion of this paragraph.
Instructions: All submissions received must include the agency name
and docket number or regulatory information number for this rulemaking.
All comments received may be posted without change to http://www.fda.gov/ohrms/dockets/default.htm
, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
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. Statutory and Regulatory Authorities
The act (21 U.S.C. 301 et. seq.), as amended by the Medical Device
Amendments of 1976 (the 1976 amendments) (Public Law 94-295), SMDA
(Public Law 101-629), FDAMA (Public Law 105-115), and the Medical
Device User Fee and Modernization Act (Public Law 107-250), established
a comprehensive system for the regulation of medical devices intended
for human use. Section 513 of the act (21 U.S.C. 360c) established
three categories (classes) of devices, defined by the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
Under section 513 of the act, FDA refers to devices that were in
commercial distribution before May 28, 1976 (the date of enactment of
the 1976 amendments), as preamendments devices. FDA classifies these
devices after it takes the following steps: (1) Receives a
recommendation from a device classification panel (an FDA advisory
committee); (2) publishes the panel's recommendation for comment, along
with a proposed regulation classifying the device; and (3) publishes a
final regulation classifying the device. FDA has classified most
preamendments devices under these procedures.
Devices that were not in commercial distribution before May 28,
1976, generally referred to as postamendments devices, are classified
automatically by statute (section 513(f) of the act) into class III
without any FDA rulemaking process. Those devices remain in class III
until FDA does the following: (1) Reclassifies the device into class I
or II; (2) issues an order classifying the device into class I or II in
accordance with section 513(f)(2) of the act; or (3) issues an order
finding the device to be substantially equivalent, in accordance with
section 513(i) of the act, to a legally marketed device that has been
classified into class I or class II. The agency determines whether new
devices are substantially equivalent to previously marketed devices by
means of premarket notification procedures in section 510(k) of the act
(21 U.S.C. 360(k)) and 21 CFR part 807 of the regulations.
Under the 1976 amendments, class II devices were defined as devices
for which there was insufficient information to show that general
controls themselves would provide reasonable assurance of safety and
effectiveness, but for which there was sufficient information to
establish performance standards to provide such assurance. SMDA
broadened the definition of class II devices to mean those devices for
which the general
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controls by themselves are insufficient to provide reasonable assurance
of safety and effectiveness, but for which there is sufficient
information to establish special controls to provide such assurance,
including performance standards, postmarket surveillance, patient
registries, development and dissemination of guidelines,
recommendations, and any other appropriate actions the agency deems
necessary (section 513(a)(1)(B) of the act).
II. Regulatory History of the Devices
In the Federal Register of March 31, 2000 (65 FR 17138), FDA issued
a final rule reclassifying 28 preamendments devices from class III
(premarket approval) into class II (special controls). FDA also
identified a summary of FDA guidance special controls that the agency
believes will reasonably ensure the safety and effectiveness of the
devices. For the tinnitus masker device (TMD), FDA identified labeling
as the special control.
III. Proposed Rule
FDA is proposing to amend the reclassification regulation of TMDs
in order to designate a special control for these devices. FDA has now
developed a guidance document for the device and, under the SMDA
provisions, is proposing to designate the special controls that, in
addition to general controls, the agency believes will reasonably
assure the safety and effectiveness of these devices. FDA is
identifying the guidance document entitled ``Class II Special Controls
Guidance Document: Tinnitus Masker Devices'' as the proposed special
control.
Following the effective date of a final rule based on this proposed
rule, any firm submitting a premarket notification (510(k)) for a new
TMD will need to address the issues covered in the special control
guidance. However, the firm needs only to show that its device meets
the recommendations of the guidance or in some other way provides
equivalent assurance of safety and effectiveness.
IV. Risks to Health
FDA has identified the following risks to health associated with
the device in the ``Class II Special Controls Guidance Document:
Tinnitus Masker Devices.'' The first column in table 1 of this document
shows the identified risks.
Table 1.--Risks to Health and Recommended Mitigation Measures
------------------------------------------------------------------------
Recommended Mitigation
Risks to Health Measures
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Side effects, including worsening tinnitus Section 8. Clinical
Testing
Section 9. Labeling
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Change in hearing Section 7. Preclinical
Testing
Section 8. Clinical
Testing
Section 9. Labeling
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Adverse tissue reaction Section 7. Preclinical
Testing
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Electrical hazards Section 7. Preclinical
Testing
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Tissue heating or cavitation (ultrasound Section 7. Preclinical
TMDs only) Testing
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Improper use Section 9. Labeling
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V. Special Controls
FDA believes that, in addition to general controls, the class II
special controls guidance document entitled ``Class II Special Controls
Guidance Document: Tinnitus Masker Devices'' are adequate controls to
address the risks to health described in section IV of this document.
The class II special controls guidance document provides information on
how to control the risks to health of device side effects, including
worsening tinnitus, change in hearing, adverse tissue reaction,
electrical hazards, tissue heating or cavitation (ultrasound TMDs
only), and improper use. The draft guidance document contains specific
recommendations with regard to device performance testing and other
information in a 510(k) submission. In table 1 of this document, FDA
has identified the risks to health associated with the use of the
device in the first column and the recommended mitigation measures
identified in the class II special controls guidance document in the
second column. These recommendations will also help ensure that the
device has appropriate performance characteristics and labeling for its
use.
Following the effective date of a final rule based on this proposed
rule, any firm submitting a 510(k) for a TMD will need to address the
issues covered in the special controls guidance. However, the firm need
only show that its device meets the recommendations of the guidance or
in some other way provides equivalent assurance of safety and
effectiveness.
VI. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VII. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
order and so is not subject to review under the Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The purpose of this proposed rule is to designate a
special control for these devices. FDA has designated guidance
documents as the special controls. FDA believes that manufacturers,
including small manufacturers, are already substantially in compliance
with the recommendations in the guidance documents and they will not
add substantially to the information manufacturers presently submit.
FDA, therefore, believes that the rule will impose no significant
economic impact on any small entities. The agency, therefore certifies
that this proposed rule will not have a significant economic impact on
a substantial number of small entities. In addition, this proposed rule
will not impose costs of $100 million or more on either the private
sector or State, local, and tribal governments in the aggregate and,
therefore, a summary statement or
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analysis under section 202(a) of the Unfunded Mandates Reform Act of
1995 is not required.
VIII. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
IX. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no
collections of information. Therefore, clearance by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501-3520) is not required.
FDA also tentatively concludes that the special controls guidance
document does not contain new information collection provisions that
are subject to review and clearance by OMB under the PRA. Elsewhere in
this issue of the Federal Register, FDA is publishing a notice
announcing the availability of the draft guidance document entitled
``Class II Special Controls Guidance Document: Tinnitus Masker
Devices.''
X. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this proposed
rule. Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments
or two paper copies of any written
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.
XI. Proposed Implementation Plan
FDA proposes that any final regulation that may issue based on this
proposal become effective 30 days after its date of publication in the
Federal Register. Following the effective date of a final rule
exempting the device, manufacturers of TMDs will need to address the
issues covered in this special controls guidance. However, the
manufacturer need only show that its device meets the recommendations
of the guidance or in some other way provides equivalent assurances of
safety and effectiveness.
List of Subjects in 21 CFR Part 874
Medical devices.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 874 be amended as follows:
PART 874--EAR, NOSE, AND THROAT DEVICES
0
1. The authority citation for 21 CFR part 874 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Section 874.1 is amended by revising paragraph (e) to read as
follows:
Sec. 874.1 Scope.
* * * * *
(e) Guidance documents in this part may be obtained on the Internet
at http://www.fda.gov/cdrh/guidance.html.
0
3. Section 874. 3400 is amended by revising paragraph (b) to read as
follows:
Sec. 874.3400 Tinnitus masker.
* * * * *
(b) Classification. Class II (special controls). The special
control for these devices is FDA's ``Class II Special Controls Guidance
Document: Tinnitus Masker Devices.''
Dated: October 7, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-22269 Filed 11-7-05; 8:45 am]
BILLING CODE 4160-01-S