[Federal Register Volume 73, Number 105 (Friday, May 30, 2008)]
[Proposed Rules]
[Pages 31040-31043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-12120]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 892

[Docket No. FDA-2008-N-0273]


Medical Devices; Radiology Devices; Reclassification of Full 
Field Digital Mammography System

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify the full field digital mammography (FFDM) system from class 
III (premarket approval) to class II (special controls). The device 
type is intended to produce full field digital x-ray images of the 
breast. Elsewhere in this issue of the Federal Register, FDA is 
announcing the availability of the draft guidance document entitled 
``Class II Special Controls Guidance Document: Full Field Digital 
Mammography System'' that would serve as the special control for the 
device, if FDA reclassifies this device type.

DATES: Submit written or electronic comments by August 28, 2008. See 
section X of this document for the proposed effective date of a final 
rule based on this proposed rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0273, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described previously, in 
the ADDRESSES portion of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to http://www.regulations.gov, including 
any personal information provided. For additional information on 
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Robert A. Phillips, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-3666.

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 
et seq.), as amended by (among other amendments) the Medical Device 
Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the Safe 
Medical Devices Act of 1990 (Public Law 101-629), and the Food and Drug 
Administration Modernization Act of 1997 (Public Law 105-115), 
established a comprehensive

[[Page 31041]]

system for the regulation of medical devices intended for human use. 
Section 513 of the act (21 U.S.C. 360c) established three categories 
(classes) of devices, depending on the regulatory controls needed to 
provide reasonable assurance of their safety and effectiveness. The 
three categories of devices are class I (general controls), class II 
(special controls), and class III (premarket approval).
    Under section 513 of the act, FDA refers to devices that were in 
commercial distribution before May 28, 1976 (the date of enactment of 
the 1976 amendments) as ``preamendments'' devices. FDA classifies these 
devices after the agency takes the following steps: (1) Receives a 
recommendation from a device classification panel (an FDA advisory 
committee); (2) publishes the panel's recommendation for comment, along 
with a proposed regulation classifying the device; and (3) publishes a 
final regulation classifying the device. FDA has classified most 
preamendments devices under these procedures.
    Under section 513 of the act, FDA refers to devices that were not 
in commercial distribution prior to May 28, 1976, as ``postamendments'' 
devices. Postamendments devices are classified automatically by statute 
(section 513(f) of the act) into class III without any FDA rulemaking 
process. These devices remain in class III and require premarket 
approval, unless the device is reclassified into class I or II or FDA 
issues an order finding the device to be substantially equivalent, 
under 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 predicate 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 the regulations.
    Reclassification of classified postamendments devices is governed 
by section 513(f)(3) of the act. This section provides that FDA may 
initiate the reclassification of a device classified into class III 
under section 513(f)(1) of the act, or the manufacturer or importer of 
a device may petition the Secretary of Health and Human Services (the 
Secretary) for the issuance of an order classifying the device into 
class I or class II. FDA's regulations in 21 CFR 860.134 set forth the 
procedures for the filing and review of a petition for reclassification 
of these class III devices. To change the classification of the device, 
the proposed new class must have sufficient regulatory controls to 
provide reasonable assurance of the safety and effectiveness of the 
device for its intended use.
    Under section 513(f)(3)(B)(i) of the act, the Secretary may ask for 
a recommendation from a device classification panel on a proposed 
reclassification, whether initiated by FDA or a petitioner. The panel 
will make a recommendation to FDA concerning the proposed 
reclassification. The recommendation must contain the following 
information: (1) A summary of the reasons for the recommendation, (2) a 
summary of the data upon which the recommendation is based, and (3) an 
identification of the risks to health (if any) presented by the device 
that is the subject of the proposed reclassification.

II. Regulatory History of the Device

    An FFDM system is a postamendments device classified into class III 
under section 513(f)(1) of the act. This generic type of device cannot 
be placed in commercial distribution unless it is reclassified under 
section 513(f)(3) or subject to an approval of a premarket approval 
(PMA) application under section 515 of the act (21 U.S.C. 360e). In 
accordance with section 513(f)(3) of the act and based on information 
regarding the device, FDA, on its own initiative, is proposing to 
reclassify this device type from class III to class II when intended to 
produce full field digital x-ray images of the breast. Consistent with 
the act and the regulation, FDA referred the proposed reclassification 
to the Radiological Devices Panel (the Panel) for its recommendation on 
the requested change in classification.

III. Device Description

    An FFDM system is a device intended to be used to produce full 
field digital x-ray images of the breast. This generic type of device 
may include one or more of the following: Digital mammography software, 
full field digital image receptor, acquisition workstation, and signal 
analysis programs. Mammographic x-ray producing equipment (x-ray 
generator, x-ray control, x-ray tube, collimator, beam filter, and 
breast compression system) and display accessories are regulated under 
21 CFR 892.1710, 892.2040, and 892.2050 as class II devices (special 
controls).

IV. Recommendations of the Panel

    At a public meeting on May 23, 2006, the Panel unanimously 
recommended that the FFDM system be reclassified from class III to 
class II (special controls). The Panel believed that class II with the 
draft special controls guidance document, in addition to general 
controls, would provide reasonable assurance of the safety and 
effectiveness of the device (Ref. 1).

V. Risks to Health

    After considering the information in the Panel's recommendation, 
published medical literature (Refs. 2 through 4), and device recalls 
(Ref. 5), FDA determined that the potential risks to health associated 
with use of the FFDM system are electrical hazards, corrupted or non-
diagnostic image, incorrect patient positioning, excessive x-ray 
exposure, excessive breast compression, and infection and skin 
irritation. FDA's draft special controls guidance document aids in 
mitigating the potential risks by recommending electrical safety 
characteristics, physical laboratory testing, clinical studies, and 
labeling. (See table 1 in section VIII of this document.)

VI. Summary of Reasons for Recommendation

    After reviewing the data provided by FDA, and after considering the 
open discussions during the Panel meeting and the Panel members' 
personal knowledge of and clinical experience with the device, the 
Panel recommended that FDA reclassify the FFDM system intended to 
produce full field digital x-ray images of the breast from class III 
into class II (special controls). The Panel believes that the special 
controls discussed in section VIII of this document, in addition to 
general controls, would provide reasonable assurance of the safety and 
effectiveness of the device, and there is sufficient information to 
establish special controls to provide this assurance (Ref. 1).

VII. Summary of Data Upon Which the Panel Recommendation Is Based

    After considering the Panel's recommendation, as well as the 
medical literature and other information, FDA believes that the 
potential risks to health associated with the FFDM system are addressed 
in the draft special controls guidance document. FDA also believes that 
the draft guidance would provide reasonable assurance of the safety and 
effectiveness of the FFDM system regarding the identified risks to 
health of this device.

VIII. Special Controls

    In addition to general controls, FDA believes that the draft 
special controls guidance document is an adequate special control to 
address the risks to health associated with the use of the device 
described in section V of this

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document. FDA believes that special controls, in addition to general 
controls, would provide reasonable assurance of the safety and 
effectiveness of the device.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of the draft guidance entitled ``Class II Special 
Controls Guidance Document: Full Field Digital Mammography System'' 
that the agency intends to use as the special control for this device. 
The draft guidance addresses the information FDA believes should be 
included in a premarket notification submission (510(k)) for the FFDM 
system. FDA has identified the risks to health associated with the use 
of the device in the first column of table 1 of this document. The 
recommended mitigation measures identified in the class II special 
controls guidance document is in the second column of table 1 of this 
document.

            Table 1.--Risks to Health and Mitigation Measures
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          Identified Risk              Recommended Mitigation  Measures
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Electrical hazards                   Electrical safety
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Corrupted or non-diagnostic image    Physical laboratory testing
                                     Clinical studies
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Incorrect patient positioning        Clinical studies
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Excessive x-ray exposure             Physical laboratory testing
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Excessive breast compression         Physical laboratory testing
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Infection, skin irritation           Labeling
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    Following the effective date of a final rule based on this 
proposal, any firm submitting a 510(k) for an FFDM system will need to 
address the issues covered in the special controls 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.

IX. FDA's Tentative Findings

    FDA and the Panel believe that the FFDM system should be 
reclassified into class II because special controls, in addition to 
general controls, would provide reasonable assurance of the safety and 
effectiveness of the device, and there is sufficient information to 
establish special controls to provide this assurance. FDA, therefore, 
is proposing to reclassify the device type from class III into class II 
with the draft guidance as the special control for the device.
    Section 510(m) of the act provides that a class II device may be 
exempted from the premarket notification requirements under section 
510(k) of the act, if the agency determines that premarket notification 
is not necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For this device, however, FDA believes 
that premarket notification is necessary to provide reasonable 
assurance of safety and effectiveness and, therefore, does not intend 
to exempt the device from the premarket notification requirements.

X. Proposed Effective Date

    FDA proposes that any final rule that may issue based on this 
proposal become effective 30 days after its date of publication in the 
Federal Register.

XI. 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.

XII. Analysis of Impacts

    FDA has examined the impacts of the proposed 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 proposed rule is not a significant regulatory action as defined by 
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. Because reclassification of this device 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 and may permit small potential competitors to enter the market 
place by lowering their costs, the agency certifies that the proposed 
rule will not have a significant economic impact on a substantial 
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $127 million, using the most current (2006) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.

XIII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed 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 tentatively concluded that the proposed 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.

XIV. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collections of information. Therefore, clearance by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(the PRA) (44 U.S.C. 3501-3520) is not required.
    FDA also tentatively concludes that the special controls guidance 
document does not contain new information collection provisions that 
are subject to review and clearance by OMB under the PRA. Elsewhere in 
this issue of the Federal Register, FDA is announcing the availability 
of the draft guidance document entitled ``Class II Special Controls 
Guidance Document: Full Field Digital Mammography System;'' the 
document addresses the paperwork burden for the draft guidance.

XV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document.

[[Page 31043]]

Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic comments and 
submissions will be accepted by FDA only through FDMS at http://www.regulations.gov.

XVI. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Radiological Devices Panel, Transcript, pp. 142-156, 
available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=659, May 23, 2006.
    2. Pisano, E., Gatsonis, C., Hendrick, E., et al., ``Digital 
Mammographic Imaging Screening Trial (DMIST) Investigators Group,'' 
``Diagnostic Performance of Digital Versus Film Mammography for 
Breast-Cancer Screening,'' New England Journal of Medicine, 353: 
1773-1783, 2005.
    3. Yaffe, M., Bloomquist, A., Mawdsley, G., et al., ``Quality 
Control for Digital Mammography: Part II Recommendations From the 
ACRIN DMIST Trial,'' Medical Physics, 33(3): 737-752, 2006.
    4. Thomas, J., Chakrabarti, K., Kaczmarek, R., et al., 
``Contrast Detail Phantom Scoring Methodology,'' Medical Physics, 
32(3), 807, 2005.
    5. Device recalls are described in FDA's briefing information, 
slide number 12, available at http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4219b1_04_draft%20FDA%20presentation.pdf.

List of Subjects in 21 CFR Part 892

    Medical device, Radiation protection, X-rays.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 892 be amended as follows:

PART 892--RADIOLOGY DEVICES

    1. The authority citation for 21 CFR part 892 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    2. Section 892.1 is amended by adding paragraph (e) to read as 
follows:


Sec.  892.1  Scope.

* * * * *
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/cdrh/guidance.html.
    3. Section 892.1715 is added to subpart B to read as follows:


Sec.  892.1715  Full field digital mammography system.

    (a) Identification. A full field digital mammography system is a 
device intended to produce full field digital x-ray images of the 
breast. This generic type of device may include one or more of the 
following: Digital mammography software, full field digital image 
receptor, acquisition workstation, and signal analysis programs.
    (b) Classification. Class II (special controls). The special 
control for the device is FDA's guidance document entitled ``Class II 
Special Controls Guidance Document: Full Field Digital Mammography 
System.'' See 892.1(e) for the availability of this guidance document.

    Dated: May 21, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-12120 Filed 5-29-08; 8:45 am]
BILLING CODE 4160-01-S