[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]                         

========================================================================
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.

-----------------------------------------------------------------------

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availability of the draft guidance document that the agency proposes to 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

Follow the instructions for submitting comments.
     Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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

[[Page 67653]]

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
------------------------------------------------------------------------
Side effects, including worsening tinnitus    Section 8. Clinical
                                               Testing
                                              Section 9. Labeling
------------------------------------------------------------------------
Change in hearing                             Section 7. Preclinical
                                               Testing
                                              Section 8. Clinical
                                               Testing
                                              Section 9. Labeling
------------------------------------------------------------------------
Adverse tissue reaction                       Section 7. Preclinical
                                               Testing
------------------------------------------------------------------------
Electrical hazards                            Section 7. Preclinical
                                               Testing
------------------------------------------------------------------------
Tissue heating or cavitation (ultrasound      Section 7. Preclinical
 TMDs only)                                    Testing
------------------------------------------------------------------------
Improper use                                  Section 9. Labeling
------------------------------------------------------------------------

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

[[Page 67654]]

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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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