Medical Devices; Exemptions From Premarket Notification; Surgical Lamps

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]

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