[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]


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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.

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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

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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

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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