[Federal Register Volume 64, Number 184 (Thursday, September 23, 1999)]
[Rules and Regulations]
[Pages 51442-51444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24791]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. 99N-4027]
Medical Devices; Gastroenterology and Urology Devices;
Classification of the Electrogastrography System
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is classifying the
electrogastrography system (EGG) into class II (special controls). The
special controls that will apply to the EGG system are restriction to
prescription use, certain labeling requirements, design requirements,
and data collection requirements. The agency is taking this action in
response to a petition submitted under the Federal Food, Drug, and
Cosmetic Act (the act) as
[[Page 51443]]
amended by the Medical Device Amendments of 1976, the Safe Medical
Devices Act of 1990, and the Food and Drug Administration Modernization
Act of 1997. The agency is classifying the EGG system into class II
(special controls) in order to provide a reasonable assurance of safety
and effectiveness of the device.
DATES: This rule becomes effective October 25, 1999. The
reclassification was effective August 20, 1999.
FOR FURTHER INFORMATION CONTACT: Carolyn Y. Neuland, Center for Devices
and Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1220
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of the act (21 U.S.C.
360c(f)(1)), devices that were not in commercial distribution before
May 28, 1976, the date of enactment of the Medical Device Amendments of
1976 (the amendments), generally referred to as postamendments devices,
are classified automatically by statute into class III without any FDA
rulemaking process. These devices remain in class III and require
premarket approval, unless and until the device is classified or
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the act, to a predicate device that does not require
premarket approval. The agency determines whether new devices are
substantially equivalent to previously marketed devices by means of
premarket notification procedures in section 510(k) of the act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807) of FDA's regulations.
Section 513(f)(2) of the act provides that any person who submits
a premarket notification under section 510(k) of the act for a device
that has not previously been classified may, within 30 days after
receiving an order classifying the device in class III under section
513(f)(1) of the act, request FDA to classify the device under the
criteria set forth in section 513(a)(1) of the act. FDA shall, within
60 days of receiving such a request, classify the device by written
order. This classification shall be the initial classification of the
device. Within 30 days after the issuance of an order classifying the
device, FDA must publish a notice in the Federal Register announcing
such classification.
In accordance with section 513(f)(1) of the act, FDA issued an
order on July 2, 1999, classifying the 3CPM EGG Machine in class III,
because it was not substantially equivalent to a device that was
introduced or delivered for introduction into interstate commerce for
commercial distribution before May 28, 1976, or a device which was
subsequently reclassified into class I or class II. On July 12, 1999,
the 3CPM Co., Inc., submitted a petition requesting classification of
the 3CPM EGG Machine under section 513(f)(2) of the act. The
manufacturer recommended that the device be classified into class II.
In accordance with 513(f)(2) of the act, FDA reviewed the petition
in order to classify the device under the criteria for classification
set forth in 513(a)(1) of the act. Devices are to be classified into
class II 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
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
petition and the medical literature, FDA determined that the EGG system
can be classified in class II with the establishment of special
controls. FDA believes these special controls will provide reasonable
assurance of safety and effectiveness of the device.
The device is assigned the generic name ``electrogastrography
system,'' and it is identified as a device used to measure gastric
myoelectrical activity as an aid in the diagnosis of gastric motility
disorders. The device system includes the external recorder, amplifier,
skin electrodes, strip chart, cables, analytical software, and other
accessories.
FDA has identified the following risks to health associated
specifically with this type of device: (1) Misdiagnosis due to
erroneous data output and (2) misuse of the device and
misinterpretation of the system results by an untrained individual.
FDA believes that the special controls described below address
these risks and provide reasonable assurance of the safety and
effectiveness of the device. Therefore, on August 20, 1999, FDA issued
an order to the petitioner classifying the device as described
previously into class II subject to the special controls described
below. Additionally, FDA is codifying the classification of this device
by adding Sec. 876.1735.
In addition to the general controls of the act, the 3CPM EGG
Machine is subject to the following special controls: (1) The sale,
distribution and use of this device are restricted to prescription use
in accordance with 21 CFR 801.109. (2) The labeling must include
specific instructions: (a) To describe proper patient set-up prior to
the start of the test, including the proper placement of electrodes;
(b) to describe how background data should be gathered and used to
eliminate artifact in the data signal; (c) to describe the test
protocol (including the measurement of baseline data) that may be
followed to obtain the EGG signal; and (d) to explain how data results
may be interpreted. (3) The device design should ensure that the EGG
signal is distinguishable from background noise that may interfere with
the true gastric myoelectric signal. (4) Data should be collected to
demonstrate that the device has adequate precision and the EGG signal
is reproducible and is interpretable.
Section 510(m) of the act provides that FDA may exempt a class II
device from the premarket notification requirements under section
510(k) of the act, if FDA determines that premarket notification is not
necessary to provide reasonable assurance of the safety and
effectiveness of the device. FDA has determined premarket notification
is necessary to provide reasonable assurance of the safety and
effectiveness of this type of device and, therefore, the type of device
is not exempt from premarket notification requirements. Thus, persons
who intend to market this type of device must submit to FDA a premarket
notification, prior to marketing the device, which contains information
about the EGG system they intend to market.
II. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
III. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the
[[Page 51444]]
final rule is not a significant regulatory action as defined by the
Executive Order and so it is not subject to review under the Executive
Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Reclassification of these devices from class III to
class II will relieve manufacturers of the device of the cost of
complying with the premarket approval requirements of section 515 of
the act (21 U.S.C. 360e), and may permit small potential competitors to
enter the marketplace by lowering their costs. The agency, therefore,
certifies that the final rule will not have a significant impact on a
substantial number of small entities. In addition, this final rule will
not impose costs of $100 million or more on either the private sector
or State, local, and tribal governments in the aggregate and,
therefore, a summary statement of analysis under section 202(a) of the
Unfunded Mandates Reform Act is not required.
IV. Paperwork Reduction Act of 1995
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
V. Reference
The following reference has been placed on display in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Petition from 3CPM Co., Inc., dated July 12, 1999.
Therefore, under the Federal Food, Drug, and Cosmetic Act and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 876 is amended as follows:
List of Subjects in 21 CFR Part 876
Medical devices.
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
1. The authority citation for 21 CFR part 876 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
2. Section 876.1735 is added to subpart B to read as follows:
Sec. 876.1735 Electrogastrography system.
(a) Identification. An electrogastrography system (EGG) is a
device used to measure gastric myoelectrical activity as an aid in the
diagnosis of gastric motility disorders. The device system includes the
external recorder, amplifier, skin electrodes, strip chart, cables,
analytical software, and other accessories.
(b) Classification. Class II (Special Controls). The special
controls are as follows:
(1) The sale, distribution and use of this device are restricted to
prescription use in accordance with Sec. 801.109 of this chapter.
(2) The labeling must include specific instructions:
(i) To describe proper patient set-up prior to the start of the
test, including the proper placement of electrodes;
(ii) To describe how background data should be gathered and used to
eliminate artifact in the data signal;
(iii) To describe the test protocol (including the measurement of
baseline data) that may be followed to obtain the EGG signal; and
(iv) To explain how data results may be interpreted.
(3) The device design should ensure that the EGG signal is
distinguishable from background noise that may interfere with the true
gastric myoelectric signal.
(4) Data should be collected to demonstrate that the device has
adequate precision and the EGG signal is reproducible and is
interpretable.
Dated: September 16, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 99-24791 Filed 9-22-99; 8:45 am]
BILLING CODE 4160-01-F