[Federal Register Volume 64, Number 59 (Monday, March 29, 1999)]
[Rules and Regulations]
[Pages 14830-14831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7746]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 874
[Docket No. 98P-0833]
Medical Devices; Exemptions From Premarket Notification; Class II
Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is publishing an order
granting a petition requesting exemption from the premarket
notification requirements for audiometers with certain limitations. FDA
is publishing this order in accordance with procedures established by
the Food and Drug Administration Modernization Act of 1997 (FDAMA).
EFFECTIVE DATE: March 29, 1999.
FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for
Devices and Radiological Health (HFZ-404), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1190.
SUPPLEMENTARY INFORMATION:
I. Statutory Background
Under section 513 of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360c), FDA must classify devices into one of three
regulatory classes: Class I, class II, or class III. FDA classification
of a device is determined by the amount of regulation necessary to
provide a reasonable assurance of safety and effectiveness. Under the
Medical Device Amendments of 1976 (the 1976 amendments (Pub. L. 94-
295)), as amended by the Safe Medical Devices Act of 1990 (the SMDA)
(Pub. L. 101-629)), devices are to be classified into class I (general
controls) if there is information showing that the general controls of
the act are sufficient to ensure safety and effectiveness; into class
II (special controls), if general controls, by themselves, are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide such assurance; and into class III (premarket
approval), if there is insufficient information to support classifying
a device into class I or class II and the device is a life-sustaining
or life-supporting device or is for a use that is of substantial
importance in preventing impairment of human health, or presents a
potential unreasonable risk of illness or injury.
Most generic types of devices that were on the market before the
date of the 1976 amendments (May 28, 1976) (generally referred to as
preamendments devices) have been classified by FDA under the procedures
set forth in section 513(c) and (d) of the act through the issuance of
classification regulations into one of these three regulatory classes.
Devices introduced into interstate commerce for the first time on or
after May 28, 1976 (generally referred to as postamendments devices)
are classified through the premarket notification process under section
510(k) of the act (21 U.S.C. 360(k)). Section 510(k) of the act and the
implementing regulations, 21 CFR part 807, require persons who intend
to market a new device to submit a premarket notification report
(510(k)) containing information that allows FDA to determine whether
the new device is ``substantially equivalent'' within the meaning of
section 513(i) of the act to a legally marketed device that does not
require premarket approval.
On November 21, 1997, the President signed into law FDAMA (Pub. L.
105-115). Section 206 of FDAMA, in part, added a new section 510(m) to
the act. Section 510(m)(1) of the act requires FDA, within 60 days
after enactment of FDAMA, to publish in the Federal Register a list for
each type of class II device that does not require a report under
section 510(k) of the act to provide reasonable assurance of safety and
effectiveness. Section 510(m) of the act further provides that a 510(k)
will no longer be required for these devices upon the date of
publication of the list in the Federal Register. FDA published that
list in the Federal Register of January 21, 1998 (63 FR 3142).
Section 510(m)(2) of the act provides that 1 day after date of
publication of the list under section 510(m)(1) of the act, FDA may
exempt a device on its own initiative or upon petition of an interested
person, if FDA determines that a 510(k) is not necessary to provide
reasonable assurance of the safety and effectiveness of the device.
This section requires FDA to publish in the Federal Register a notice
of intent to exempt a device, or of the petition, and to provide a 30-
day comment period. Within 120 days of publication of this document,
FDA must publish in the Federal Register its final determination
regarding the exemption of the device that was the subject of the
notice. If FDA fails to respond to a petition under this section within
180 days of receiving it, the petition shall be deemed granted.
[[Page 14831]]
II. Criteria for Exemption
There are a number of factors FDA may consider to determine
whether a 510(k) is necessary to provide reasonable assurance of the
safety and effectiveness of a class II device. These factors are
discussed in the guidance the agency issued on February 19, 1998,
entitled ``Procedures for Class II Device Exemptions from Premarket
Notification, Guidance for Industry and CDRH Staff.'' That guidance can
be obtained through the World Wide Web on the CDRH home page at
``http://www.fda.gov/cdrh'' or by facsimile through CDRH Facts-on-
Demand at 1-800-899-0381 or 301-827-0111. Specify ``159'' when prompted
for the document shelf number.
III. Petitions
FDA has received a petition requesting an exemption from premarket
notification for the audiometer (21 CFR 874.1050).
In the Federal Register of November 18, 1998 (63 FR 64091), FDA
published a notice announcing that this petition had been received and
providing an opportunity for interested persons to submit comments on
the petition by December 18, 1998. FDA received one comment that
supported the proposal. FDA has reviewed the petition and has
determined that this device meets the criteria for exemption described
previously, provided that certain conditions are met. The petitioner
stated that manufacturers of audiometers voluntarily comply with a
consensus standard for audiometers, American National Standards
Institute (ANSI), S3.6 (R1996)\1\. FDA believes that compliance with
this standard obviates the need for premarket notifications and is,
therefore, issuing this order exempting these devices from the
requirements of premarket notification, provided that they are in
compliance with this standard, and is codifying this order in the Code
of Federal Regulations. Audiometers that do not comply with this
standard are not exempt from the premarket notification requirements.
FDA also notes that otoacoustic emissions test devices are not exempt
from the the premarket notification requirements. Because the
otoacoustic emissions test device is not a type of audiometer, it is
not completely covered by the ANSI standard and, therefore, is not
subject to the exemption.
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\1\ The standard is available from the American National
Standards Institute, Standards Secretariat, Acoustical Society of
America, 120 Wall St., 32d Floor, New York, NY 10005-3993.
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IV. Environmental Impact
The agency has determined under 21 CFR 25.30(h) 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.
V. 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), as
amended by subtitle D of the Small Business Regulatory Fairness Act of
1996 (Pub. L. 104-121) and the Unfunded Mandates Reform Act of 1995
(Pub. L. 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 is not subject to
review under the Executive Order.
If a rule has a significant economic impact on a substantial
number of small entities, the Regulatory Flexibility Act requires
agencies to analyze regulatory options that would minimize any
significant impact of a rule on small entities. Because this rule will
relieve a burden and simplify the marketing of these devices, the
agency certifies that the final rule will not have a significant
economic impact on a substantial number of small entities. Therefore,
under the Regulatory Flexibility Act, no further analysis is required.
VI. Paperwork Reduction Act of 1995
FDA concludes that 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 874.1050 is amended by revising paragraph (b) to read
as follows:
Sec. 874.1050 Audiometer.
* * * * *
(b) Classification. Class II. Except for the otoacoustic emission
device, the device is exempt from the premarket notification procedures
in subpart E of part 807 of this chapter, if it is in compliance with
American National Standard Institute S3.6-1996, ``Specification for
Audiometers,'' and subject to the limitations in Sec. 874.9.
Dated: March 24, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-7746 Filed 3-26-99; 8:45 am]
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