[Federal Register Volume 68, Number 144 (Monday, July 28, 2003)]
[Rules and Regulations]
[Pages 44414-44415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19029]



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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

  Federal Register / Vol. 68, No. 144 / Monday, July 28, 2003 / Rules 
and Regulations  

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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

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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

0
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.

0
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.

0
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