[Federal Register Volume 67, Number 16 (Thursday, January 24, 2002)]
[Rules and Regulations]
[Pages 3431-3433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-1722]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. 01P-0304]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Ingestible Telemetric Gastrointestinal Capsule Imaging System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
ingestible telemetric gastrointestinal capsule imaging system device 
into class II (special controls). The special controls that will apply 
to this device are set forth below. The agency is taking this action in 
response to a petition submitted under the Federal Food, Drug, and 
Cosmetic Act (the act) as amended by the Medical Device Amendments of 
1976 (the amendments), the Safe Medical Devices Act of 1990, and the 
Food and Drug Administration Modernization Act of 1997 (FDAMA). The 
agency is classifying this device into class II (special controls) in 
order to provide a reasonable assurance of safety and effectiveness of 
the device.

DATES: This rule is effective February 25, 2002.

FOR FURTHER INFORMATION CONTACT: Carolyn 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 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 21 CFR part 807 of the FDA 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.

[[Page 3432]]

    On June 11, 2001, FDA received a petition submitted under section 
513(f)(2) of the act by Given Imaging, Ltd., through Hogan & Hartson, 
L.L.P., seeking an evaluation of the automatic class III designation of 
its GIVEN Diagnostic Imaging System (GIVEN System). In accordance with 
section 513(f)(1) of the act, FDA issued an order automatically 
classifying the GIVEN System 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 that was subsequently reclassified 
into class I or II. After reviewing information submitted in the 
petition, FDA determined that the GIVEN System can be classified in 
class II with the establishment of special controls. This device is 
intended for visualization of the small bowel mucosa as an adjunctive 
tool in the detection of abnormalities of the small bowel. FDA believes 
that class II special controls, in addition to the general controls, 
will provide reasonable assurance of the safety and effectiveness of 
the device.
    FDA has identified the following risks to health associated 
specifically with this type of device: (1) Biocompatibility; (2) 
electrical and mechanical safety; (3) radio-frequency radiated power 
and electromagnetic compatibility, including interference with other 
medical devices and with this device (e.g., interference with image 
acquisition); (4) functional reliability, including structural 
integrity and image acquisition; (5) intestinal obstruction or injury; 
and (6) misinterpretation of the captured images. Therefore, in 
addition to the general controls of the act, the device is subject to a 
special controls guidance document entitled ``Class II Special Controls 
Guidance Document: Ingestible Telemetric Gastrointestinal Capsule 
Imaging System; Final Guidance for Industry and FDA.''
    The class II special controls guidance provides information on how 
to meet premarket (510(k)) submission requirements for the device, 
including testing standards for biocompatibility, and electrical and 
mechanical performance. The class II special controls guidance also 
includes appropriate prescription and patient labeling. FDA believes 
that adherence to the class II special controls addresses the risks to 
health identified above and provides a reasonable assurance of the 
safety and effectiveness of the device.
    Section 510(m) of the act provides that FDA may exempt a class II 
device from the premarket notification requirement 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. For this type of device, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of safety and effectiveness and, therefore, the 
device is not exempt from the premarket notification requirements. The 
device is used for visualization of the small bowel mucosa as an 
adjunctive tool in the detection of abnormalities of the small bowel. 
FDA review of key design features, data sets from bench studies and 
clinical trials, other relevant performance data, and labeling will 
ensure that acceptable levels of performance for both safety and 
effectiveness are addressed before marketing clearance. Thus, persons 
who intend to market this device must submit to FDA a premarket 
notification submission containing information on the ingestible 
telemetric gastrointestinal capsule imaging system before marketing the 
device.
    On August 1, 2001, FDA issued an order classifying the GIVEN System 
and substantially equivalent devices of this generic type into class II 
under the generic name, ingestible telemetric gastrointestinal capsule 
imaging system. FDA identifies this generic type of device as an 
ingestible telemetric gastrointestinal capsule imaging system, which is 
intended for visualization of the small bowel mucosa as an adjunctive 
tool in the detection of abnormalities in the small bowel.
    FDA is codifying this device by adding Sec. 876.1300. The order 
also identifies a special control applicable to this device a guidance 
document entitled ``Class II Special Controls Guidance Document: 
Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final 
Guidance for Industry and FDA.''

II. Electronic Access

    In order to receive the guidance entitled ``Class II Special 
Controls Guidance Document: Ingestible Telemetric Gastrointestinal 
Capsule Imaging System; Final Guidance for Industry and FDA'' via your 
fax machine, call the CDRH Facts-on-Demand system at 800-899-0381 or 
301-827-0111 from a touch-tone telephone. At the first voice prompt 
press 1 to enter the system. At the second voice prompt press 1 to 
order a document. Enter the document number (1385) followed by the 
pound sign (#). Follow the remaining voice prompts to complete your 
request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the Internet. CDRH maintains an entry on the Internet for easy 
access to information including text, graphics, and files that may be 
downloaded to a personal computer with Internet access. Updated on a 
regular basis, the CDRH home page includes the civil money penalty 
guidance documents package, device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh. The document entitled ``Class II Special Controls Guidance 
Document: Ingestible Telemetric Gastrointestinal Capsule Imaging 
System; Final Guidance for Industry and FDA'' is available on the 
Internet at http://www.fda.gov/cdrh/ode/guidance/1385.pdf.

III. 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.

IV. 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) (as 
amended by subtitle D of the Small Business Regulatory Act of 1996 
(Public Law 104-121)), 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 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. FDA knows of only one manufacturer of this type of 
device.

[[Page 3433]]

 Classification 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.

V. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the order and, consequently, a federalism 
summary impact statement is not required.

VI. 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.

List of Subjects in 21 CFR Part 876

    Medical devices.

    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:

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 876.1300 is added to subpart B to read as follows:


Sec. 876.1300  Ingestible telemetric gastrointestinal capsule imaging 
system.

    (a) Identification. An ingestible telemetric gastrointestinal 
capsule imaging system is used for visualization of the small bowel 
mucosa as an adjunctive tool in the detection of abnormalities of the 
small bowel. The device captures images of the small bowel with a 
wireless camera contained in a capsule. This device includes an 
ingestible capsule (containing a light source, camera, transmitter, and 
battery), an antenna array, a receiving/recording unit, a data storage 
device, computer software to process the images, and accessories.
    (b) Classification. Class II (special controls). The special 
control is FDA's guidance, ``Class II Special Controls Guidance 
Document: Ingestible Telemetric Gastrointestinal Capsule Imaging 
Systems; Final Guidance for Industry and FDA.''

    Dated: January 14, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-1722 Filed 1-23-02; 8:45 am]
BILLING CODE 4160-01-S