[Federal Register Volume 63, Number 188 (Tuesday, September 29, 1998)]
[Notices]
[Pages 51940-51941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25916]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket Nos. 98N-0473, 98P-0215, 98P-0216, 98P-0275, 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 an order 
denying four petitions requesting exemptions for five devices from the 
premarket notification requirements for certain class II devices. FDA 
is publishing this notice in accordance with procedures established by 
the Food and Drug Administration Modernization Act of 1997 (FDAMA).

EFFECTIVE DATE: September 29, 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 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

    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.
    On July 21, 1998 (63 FR 39098), FDA published a notice announcing 
that

[[Page 51941]]

these petitions had been received and providing an opportunity for 
interested persons to submit comments on the petitions by August 20, 
1998. FDA received no comments. FDA has reviewed these petitions and, 
for the following reasons, has determined that these devices do not 
meet the criteria for exemption described previously and is, therefore, 
issuing this order denying the petitions to exempt these devices from 
the requirements of premarket notification.
    1. Gastrointestinal motility monitoring system. Gastrointestinal 
motility monitoring systems could include a wide variety of devices to 
measure and assess the functioning of the gastrointestinal tract. The 
gastrointestinal monitoring systems including such components as 
electronic instruments, recorders, displays, and software are viewed as 
integral components of the system and must be evaluated together with 
the monitoring probes or catheters. FDA believes that review of all 
components of the system is necessary to provide adequate labeling and 
to ensure the safety and effectiveness of these products in comparison 
to legally marketed devices of this type.
    The submission has not provided sufficient information that 
demonstrates that the characteristics and labeling, which are necessary 
to determine acceptable device performance, are well established. 
Further, it is neither apparent, nor has it been established, that 
changes in the device that could affect safety and effectiveness, and 
lead to device errors, would either: (a) Be readily detectable by users 
by visual examination or other means, such as routine testing, before 
causing harm; or (b) not materially increase the risk of incorrect 
output potentially leading to incorrect diagnosis.
    2. Ophthalmoscope. The petition, as presented, does not meet the 
criteria for exemption, because changes in the device that could affect 
safety and effectiveness would not be readily detectable by users by 
visual examination or routine testing. Specifically, hazards causing 
retinal phototoxicity have long been recognized to be associated with 
the retinal exposure of the light (including, especially, invisible 
infrared and ultraviolet wavelengths). In addition, FDA requires 
testing to determine the amount of light emitted and has established 
maximum exposure levels to mitigate this risk. The potential sight-
threatening hazard from retinal phototoxicity due to exposure to the 
light from the ophthalmoscope cannot be determined without appropriate 
measurements of the exposure level. The need for special controls has 
been recognized nationally (American National Standards Institute) and 
internationally (International Standards Organization). In the near 
future, FDA intends to propose special controls for the ophthalmoscope 
and, at the same time, intends to propose to exempt them from the 
premarket notification requirements. Until the establishment of such 
controls, however, the characteristics of the device necessary for its 
safe and effective performance are not well established and changes in 
the use of the device may result in materially increasing the risk of 
injury. Accordingly, the device will not presently be exempt from 
premarket review.
    3. Radiation Oncologist Data Entry Workstation. Radiation therapy 
and radiation therapy dose calculation is an exacting procedure. The 
goal is to maintain the actual dose to within 5 percent of that 
prescribed. The data entry workstation provides data input to the 
radiation treatment planning system (RTP) on patient contours and tumor 
volumes and boundaries. It, therefore, is providing measurement 
information to the computer that is specific to a particular patient 
and fundamental to the accuracy of any subsequent treatment planning. 
As such, the workstation must be regarded as an integral component of 
the RTP system.
    Radiation therapy systems and RTP systems are high-risk devices. 
Providing an incorrect treatment dose that is too low can result in 
tumor regrowth. Providing an incorrect treatment dose that is too high 
can lead to unacceptable complications. Malfunctions of these device 
types have resulted in patient deaths.
    The submission has not provided sufficient information to establish 
that the characteristics of the device necessary for its safe and 
effective performance are well established. Further, since that 
workstation operates by direct connection to the RTP system, it is 
neither apparent, nor has it been established, that changes in the 
device that could affect safety and effectiveness or device errors 
would either: (a) Be readily detectable by users by visual examination 
or other means such as routine testing, before causing harm, e.g., 
testing of a clinical laboratory reagent with positive and negative 
controls; or (b) not materially increase the risk of injury, incorrect 
diagnosis, or ineffective treatment.
    4. Cytomegalovirus serological reagents. Cytomegalovirus infection 
is the most common identified cause of congenital infection. It has 
been reported that fewer than 5 percent of these infants develop 
symptoms during the newborn period. Cytomegalovirus infections are 
frequent and occasionally severe in children and adults with congenital 
and acquired cellular immunity defects, such as those with acquired 
immunodeficiency syndrome (AIDS), in cancer patients (especially those 
with leukemia), and in those who have received organ transplants. FDA 
believes that errors caused by these devices could materially increase 
the risk of injury, incorrect diagnosis, or ineffective treatment.
    5. Varicella-zoster virus serological reagents. Varicella-zoster 
infection may cause severe or fatal disease in individuals who are 
receiving immunosuppressive therapy or who have an immune response 
defect. A specific diagnosis of this infection in immunosuppressed 
individuals may guide the clinician in appropriate therapy. This device 
would also be useful to evaluate the effect of vaccine in patients. FDA 
believes that errors caused by these devices could materially increase 
the risk of injury, incorrect diagnosis, or ineffective treatment.

    Dated: September 23, 1998.
 William B. Schultz,
 Deputy Commissioner for Policy.
[FR Doc. 98-25916 Filed 9-28-98; 8:45 am]
BILLING CODE 4160-01-F