[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]
BILLING CODE 4160-01-F