[Federal Register Volume 63, Number 222 (Wednesday, November 18, 1998)]
[Notices]
[Pages 64091-64092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30813]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98P-0833]


Medical Devices; Exemptions From Premarket Notification; Class II 
Devices

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing notice of 
a petition requesting exemption from the premarket notification 
requirements for a class II device, the audiometer. FDA is publishing 
this notice in order to obtain comments on this petition in accordance 
with procedures established by the Food and Drug Administration 
Modernization Act of 1997 (FDAMA).

DATES:  Written comments by December 18, 1998.

ADDRESSES: Submit written comments on this notice to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

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 (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 assure 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 which 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 
preamendment 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 postamendment 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)(1) 
of the act which requires FDA, within 60 days after enactment of FDAMA, 
to publish in the Federal Register a list of each

[[Page 64092]]

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 the date 
of publication of the list under section 510(m)(1), 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, 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.

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. Petition

     FDA has received the following petition requesting an exemption 
from premarket notification for a class II device:
     1. Hearing Industries Association, 21 CFR 874.1050, Audiometer.

IV. Comments

     Interested persons may, on or before December 18, 1998, submit to 
the Dockets Management Branch (address above) written comments 
regarding this notice. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. The petition and received comments may be seen in the 
office above between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 5, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-30813 Filed 11-17-98; 8:45 am]
BILLING CODE 4160-01-F