Medical Devices; Exemptions From Premarket Notification; Class II Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 98P-0425, 98P-0506, and 98P-0621]

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 a list of

petitions requesting exemption from the premarket notification

requirements for certain class II devices. FDA is publishing this

notice in order to obtain comments on these petitions in accordance

with procedures established by the Food and Drug Administration

Modernization Act of 1997 (FDAMA).

DATES: Written comments by October 30, 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 (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

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 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. List of Petitions

FDA has received the following petitions requesting an exemption

from premarket notification for class II devices:

[[Page 52276]]

1. Abbott Laboratories, 21 CFR 862.1715 Triiodothyronine uptake

test system devices.

2. Radiological Imaging Technology, 21 CFR 892.5050, Film Dosimetry

System, a.k.a. Film Scanning System.

3. Getinge/Castle, Inc., 21 CFR 878.4580 Surgical Lamps.

IV. Comments

Interested persons may, on or before October 30, 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 petitions and received comments may be seen in the

office above between 9 a.m. and 4 p.m., Monday through Friday.

Dated: September 23, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98-26082 Filed 9-29-98; 8:45 am]

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