[Federal Register Volume 63, Number 139 (Tuesday, July 21, 1998)]
[Notices]
[Pages 39098-39099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19316]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket Nos. 98N-0473, 98P-0275, 98P-0215, 98P-0216, and 98P-0338]


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 August 20, 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 
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 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

[[Page 39099]]

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:
    1. Sandhill Scientific Inc., 21 CFR 876.1725 Gastrointestinal 
motility monitoring system.
    2. Welch Allyn, Inc., 21 CFR 886.1570 Ophthalmoscope.
    3. Computerized Medical Systems, Inc., 21 CFR 892.5840 Radiation 
therapy simulation system, exemption requested only for Radiation 
Oncologist Data Entry Workstation.
    4. Chemicon International Inc., 21 CFR 866.3175 Cytomegalovirus 
serological reagents, and 21 CFR 866.3900 Varicella-zoster virus 
serological reagents.

IV. Comments

    Interested persons may, on or before August 20, 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: July 10, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-19316 Filed 7-20-98; 8:45 am]
BILLING CODE 4160-01-F