[Federal Register: November 7, 2002 (Volume 67, Number 216)]
[Rules and Regulations]
[Page 67789-67790]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07no02-5]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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