[Federal Register Volume 63, Number 233 (Friday, December 4, 1998)]
[Notices]
[Pages 67075-67076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32248]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98P-0425]


Medical Devices; Exemptions From Premarket Notification; Surgical 
Lamps

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing an order 
denying a petition requesting an exemption from the premarket 
notification requirements for surgical lamps. FDA is publishing this 
notice in accordance with procedures established by the Food and Drug 
Administration Modernization Act of 1997 (FDAMA).

EFFECTIVE DATE: December 4, 1998.

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 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 
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 of 
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), FDA may exempt a 
device on its own initiative or upon petition of an

[[Page 67076]]

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.

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

    On June 17, 1998, FDA received a petition requesting an exemption 
from premarket notification for surgical lamps from Getinge/Castle, 
Inc. On September 30, 1998 (63 FR 52275), FDA published a notice 
announcing that it had received three petitions, including the one from 
Getinge/Castle, Inc., requesting exemption from premarket notification 
for class II devices and providing an opportunity for interested 
persons to submit comments on the petitions by October 30, 1998. FDA 
received no comments. FDA has reviewed these petitions and, for the 
following reasons, has determined that surgical lamps do not meet the 
criteria for exemption described previously and is, therefore, issuing 
this order denying the petition to exempt these devices from the 
requirements of premarket notification. The other two petitions will be 
addressed separately in another issue of the Federal Register.
    FDA has determined from its medical devices reporting (MDR) 
database that there is a risk of over-exposure to ultraviolet (UV) 
light from surgical lamps and there is a risk of surgical lamps falling 
on surgical personnel during use. FDA has recently completed a guidance 
document for surgical lamps entitled ``Guidance Document for Surgical 
Lamp 510(k)s.'' FDA is also aware of a draft standard from the 
International Electrotechnical Commission (IEC), IEC-60601-2-41, that 
would be applicable. FDA believes that the guidance and the draft 
standard would address the risks to health presented by surgical lamps. 
At some time in the future, FDA may adopt the guidance document and the 
IEC standard as special controls for surgical lamps. Without the 
guidance and the IEC standard as special controls, FDA believes that 
premarket notification is necessary to provide reasonable assurance of 
the safety and effectiveness of sunlamps.

    Dated: November 23, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-32248 Filed 12-3-98; 8:45 am]
BILLING CODE 4160-01-F