[Federal Register: July 28, 2003 (Volume 68, Number 144)]
[Rules and Regulations]
[Page 44413-44415]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jy03-18]
[[Page 44413]]
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Part III
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Part 884
Classification of the Breast Lesion Documentation System and Notice of
Availability of Guidance Document; Final Rule and Notice
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 884
[Docket No. 2003P-0301]
Medical Devices; Obstetrical and Gynecological Devices;
Classification of the Breast Lesion Documentation System
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
breast lesion documentation system into class II (special controls).
The special controls that will apply to this device are discussed later
in this document. 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. Elsewhere in this issue of the Federal Register, FDA is
publishing a notice of availability of a guidance document that is the
special control for this device.
DATES: This rule is effective August 27, 2003.
FOR FURTHER INFORMATION CONTACT: Colin Pollard, Center for Devices and
Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1180.
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.
On May 28, 2002, FDA received a petition submitted under section
513(f)(2) of the act by Assurance Medical, Inc., through Hogan &
Hartson, L.L.P., seeking an evaluation of the automatic class III
designation of its BREASTVIEW Visual Mapping System. In accordance with
section 513(f)(1) of the act, FDA issued an order on April 30, 2002,
automatically classifying the BREASTVIEW Visual Mapping 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
BREASTVIEW Visual Mapping System can be classified in class II with the
establishment of special controls. This device is intended for use in
producing a surface map of the breast as an aid to document palpable
breast lesions identified during a clinical breast exam. 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) Failure to produce an
appropriate map, (2) misinterpretation of displayed images, (3)
improper use, (4) skin irritation or toxicity, (5) electrical shock,
(6) electromagnetic interference, and (7) tissue trauma from mechanical
injury. 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: Breast Lesion
Documentation System.''
The class II special controls guidance provides information on how
to meet premarket (510(k)) submission requirements for the device,
including recommendations for labeling, information on material safety,
performance characteristics, bench testing, and software information.
FDA believes that adherence to the class II special controls addresses
the risks to health identified previously and provides a reasonable
assurance of the safety and effectiveness of the device. Following the
effective date of this final classification rule, any firm submitting a
510(k) premarket notification for a breast lesion documentation system
will need to address the issues covered in the special control
guidance. However, the firm need only show that its device meets the
recommendations of the guidance or in some other way provides
equivalent assurances of safety and effectiveness.
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 in producing a surface map of the breast as an aid to
document palpable breast lesions identified during a clinical breast
exam. 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 breast lesion
documentation system before marketing the device.
On January 31, 2003, FDA issued an order classifying the BREASTVIEW
Visual Mapping System and substantially equivalent devices of this
generic type into class II under the generic name, breast lesion
documentation system. FDA identifies this generic type of device as a
breast lesion documentation system, which is intended for use in
producing a surface map of the breast as an aid to document
[[Page 44415]]
palpable breast lesions identified during a clinical breast exam.
FDA is codifying this device by adding Sec. 884.2990. The order
also identifies a special control applicable to this device, a guidance
document entitled ``Class II Special Controls Guidance Document: Breast
Lesion Documentation System'' For the convenience of the reader, FDA is
also adding Sec. 884.1(e) to inform the reader where to find guidance
documents referenced in 21 CFR part 884.
II. Electronic Access
In order to receive the guidance entitled ``Class II Special
Controls Guidance Document: Breast Lesion Documentation System'' 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 (1202) followed by the
pound sign ([numsign]). 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
cleared/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
.
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 and 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 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. 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 Executive 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 884
Medical devices.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
884 is amended as follows:
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
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1. The authority citation for 21 CFR part 884 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
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2. Section 884.1 is amended by adding paragraph (e) to read as follows:
Sec. 884.1 Scope.
* * * * *
(e) Guidance documents referenced in this part are available on the
Internet at http://www.fda.gov/cdrh/guidance.html.
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3. Section 884.2990 is added to subpart C to read as follows:
Sec. 884.2990 Breast lesion documentation system.
(a) Identification. A breast lesion documentation system is a
device for use in producing a surface map of the breast as an aid to
document palpable breast lesions identified during a clinical breast
examination.
(b) Classification. Class II (special controls). The special
control is FDA's guidance entitled ``Class II Special Controls Guidance
Document: Breast Lesion Documentation System.'' See Sec. 884.1(e) for
the availability of this guidance document.
Dated: July 17, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-19029 Filed 7-25-03; 8:45 am]
BILLING CODE 4160-01-S