[Federal Register: January 24, 2002 (Volume 67, Number 16)]
[Rules and Regulations]
[Page 3431-3433]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ja02-4]
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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