[Federal Register Volume 67, Number 216 (Thursday, November 7, 2002)]
[Rules and Regulations]
[Pages 67789-67790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28398]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 874

[Docket No. 02P-0241]


Medical Devices; Ear, Nose, and Throat Devices; Classification of 
the Transcutaneous Air Conduction Hearing Aid System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
transcutaneous air conduction hearing aid system (TACHAS) into class II 
(special controls). Elsewhere in this issue of the Federal Register, 
FDA is announcing the availability of a guidance document that will 
serve as the special control for the device. The agency is taking this 
action in response to a petition submitted under the Federal Food, 
Drug, and Cosmetic Act (the act) as amended by the Medical Device 
Amendments of 1976 (the amendments), the Safe Medical Devices Act of 
1990, and the Food and Drug Administration Modernization Act of 1997 
(FDAMA). The agency is classifying this device into class II (special 
controls) in order to provide a reasonable assurance of safety and 
effectiveness of the device.

DATES: This rule is effective November 7, 2002.

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.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the act (21 U.S.C. 
360c(f)(1)), devices that were not in commercial distribution before 
May 28, 1976, the date of enactment of the amendments, generally 
referred to as postamendments devices, are classified automatically by 
statute into class III without any FDA rulemaking process. These 
devices remain in class III and require premarket approval, unless and 
until the device is classified or reclassified into class I or II or 
FDA issues an order finding the device to be substantially equivalent, 
in accordance with section 513(i) of the act, to a predicate device 
that does not require premarket approval. 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 FDA regulations. 
Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act for a device 
that has not previously been classified may, within 30 days after 
receiving an order classifying the device in class III under section 
513(f)(1) of the act, request FDA to classify the device under the 
criteria set forth in section 513(a)(1) of the act. FDA shall, within 
60 days of receiving such a request, classify the device by written 
order. This classification shall be the initial classification of the 
device. Within 30 days after issuing an order classifying the device, 
FDA must publish a document in the Federal Register announcing the 
classification.
    On June 21, 2002, FDA received a petition submitted under section 
513(f)(2) of the act by Auric Hearing Systems Inc., seeking an 
evaluation of the automatic class III designation of its RetroX device. 
This device is intended to compensate for impaired hearing without 
occluding the ear canal. In accordance with section 513(f)(1) of the 
act, FDA issued an order automatically classifying the RetroX device in 
class III because it was not substantially equivalent to a device that 
was introduced or delivered for introduction into interstate commerce 
for commercial distribution before May 28, 1976, or a device that was 
subsequently reclassified into class I or II. After reviewing 
information submitted in the petition, FDA determined that the RetroX 
device and substantially equivalent devices can be classified in class 
II with the establishment of special controls. FDA believes that class 
II special controls, in addition to the general controls, will provide 
reasonable assurance of the safety and effectiveness of the device.
    FDA has identified the following risks to health associated 
specifically with this type of device: (1) Infection /local 
inflammation, (2) injury to the ear canal, and (3) ineffective 
amplification.
    Therefore, in addition to the general controls of the act, the 
device is subject to a special control guidance document entitled 
``Class II Special Controls Guidance Document: Transcutaneous Air 
Conduction Hearing Aid System (TACHAS); Guidance for Industry and 
FDA.''
    FDA believes the following controls identified in the class II 
special controls guidance document for a TACHAS device, when combined 
with the general controls of the act, will provide reasonable assurance 
of the safety and effectiveness of this type device: (1) Electro-
acoustic testing, (2) fatigue testing, (3) strength test validation, 
(4) biocompatibility, (5) sterility, (6) clinical information, and (7) 
labeling to include prescription labeling in accordance with 21 CFR 
801.109.
    FDA believes that adherence to the class II special controls 
addresses the risks to health identified previously in this section of 
this document and provides a reasonable assurance of the safety and 
effectiveness of the device.
    Section 510(m) of the act provides that FDA may exempt a class II 
device from the premarket notification requirement under section 510(k) 
of the act, if FDA determines that premarket notification is not 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For this type of device, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of safety and effectiveness and, therefore, the 
device is not exempt from the premarket notification requirements. The 
device is used as a wearable sound-amplifying device intended to 
compensate for impaired hearing without occluding the ear canal. FDA 
review of key design

[[Page 67790]]

features, data sets from bench studies and clinical trials, other 
relevant performance data, and labeling will ensure that acceptable 
levels of performance for both safety and effectiveness are addressed 
before marketing clearance. Thus, persons who intend to market this 
device type must submit to FDA a premarket notification submission 
containing information on the TACHAS they intend to market prior to 
marketing the device.
    On August 20, 2002, FDA issued an order classifying the RetroX 
device and substantially equivalent devices of this generic type into 
class II under the generic name, transcutaneous air conduction hearing 
aid system. FDA identifies this generic type of device as:
    A wearable sound-amplifying device intended to compensate for 
impaired hearing without occluding the ear canal. The device 
consists of an air conduction hearing aid attached to a surgically 
fitted tube system, which is placed through soft tissue between the 
post auricular region and the outer ear canal.
The order also identifies a special control applicable to this device a 
guidance document entitled ``Class II Special Controls Guidance 
Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); 
Guidance for Industry and FDA.'' Any firm submitting a 510(k) premarket 
notification for the device would need to address the issues covered in 
the special control guidance. However, the firm would need to show only 
that its device meets the recommendations of the guidance or in some 
other way provides equivalent assurances of safety and effectiveness.
    FDA is now codifying the classification and the special control by 
adding new Sec.  874.3950. For the convenience of the reader, FDA is 
also adding a new Sec.  874.1(e) to inform the reader where to find 
guidance documents referenced in 21 CFR part 874.

II. 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.

III. Analysis of Impacts

    FDA has examined the impacts of the final 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 final rule is consistent with the regulatory philosophy and 
principles identified in the Executive order. In addition, the final 
rule is not a significant regulatory action as defined by the Executive 
order and so it 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. FDA knows of only one manufacturer of this type of 
device. Classification of these devices from class III to class II will 
relieve manufacturers of the device of the cost of complying with the 
premarket approval requirements of section 515 of the act (21 U.S.C. 
360e), and may permit small potential competitors to enter the 
marketplace by lowering their costs. The agency, therefore, certifies 
that the final rule will not have a significant impact on a substantial 
number of small entities. In addition, this final 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 of analysis under section 202(a) of the Unfunded 
Mandates Reform Act is not required.

IV. 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 order and, consequently, a federalism 
summary impact statement is not required.

V. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

List of Subjects in 21 CFR Part 874

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
874 is amended as follows:

PART 874--EAR, NOSE, AND THROAT DEVICES

    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.

    2. Section 874.1 is amended by adding paragraph (e) to read as 
follows:


Sec.  874.1  Scope.

* * * * *
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/cdrh/guidance.html

    3. Section 874.3950 is added to subpart D to read as follows:


Sec.  874.3950  Transcutaneous air conduction hearing aid system.

    (a) Identification. A transcutaneous air conduction hearing aid 
system is a wearable sound-amplifying device intended to compensate for 
impaired hearing without occluding the ear canal. The device consists 
of an air conduction hearing aid attached to a surgically fitted tube 
system, which is placed through soft tissue between the post auricular 
region and the outer ear canal.
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's guidance document entitled ``Class II 
Special Controls Guidance Document: Transcutaneous Air Conduction 
Hearing Aid System (TACHAS); Guidance for Industry and FDA.'' See Sec.  
874.1 for the availability of this guidance document.

    Dated: October 28, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-28398 Filed 11-6-02; 8:45 am]
BILLING CODE 4160-01-S