[Federal Register: September 29, 1998 (Volume 63, Number 188)]
[Notices]
[Page 51940-51941]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se98-107]

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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