Document ID: FDA-2008-N-0273-0018
Agency: fda
Document Type: Rule
Title: Medical Devices: Radiology Devices; Reclassification of Full-Field Digital Mammography System
Posted Date: 2010-11-05T04:00Z

[Federal Register Volume 75, Number 214 (Friday, November 5, 2010)]
[Rules and Regulations]
[Pages 68200-68203]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28007]

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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
reclassification of the full-field digital mammography (FFDM) system 
from class III (premarket approval) to class II (special controls). The 
device type is intended to produce planar digital x-ray images of the 
entire breast; this generic type of device may include digital 
mammography acquisition software, full-field digital image receptor, 
acquisition workstation, automatic exposure control, image processing 
and reconstruction programs, patient and equipment supports, component 
parts, and accessories. The special control that will apply to the 
device is the guidance document entitled ``Class II Special Controls 
Guidance Document: Full-Field Digital Mammography System.'' FDA is 
reclassifying the device into class II (special controls) because 
general controls along with special controls will provide a reasonable 
assurance of safety and effectiveness of the device. Elsewhere in this 
issue of the Federal Register, FDA is announcing the availability of 
the guidance document that will serve as the special control for this 
device.

DATES: This rule is effective December 6, 2010.

FOR FURTHER INFORMATION CONTACT:

Mary Pastel, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. G304, Silver 
Spring, MD 20993-0002, 301-796-6887; or
Kyle J. Myers, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 62, rm. 3118, 
Silver Spring, MD 20993-0002, 301-796-2533.

SUPPLEMENTARY INFORMATION:

I. Statutory Framework for Device Classification

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
301 et seq.), as amended by the Medical Device Amendments of 1976 (Pub. 
L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the 
Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 
105-115), and the Food and Drug Administration Amendments Act of 2007 
(Pub. L. 110-85), among other amendments, established a comprehensive 
system for the regulation of medical devices intended for human use. 
Section 513 of the FD&C 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 FD&C 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 has taken 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 type.
    FDA has classified most preamendments devices under these 
procedures.
    FDA refers to devices that were not in commercial distribution 
before May 28, 1976, as ``postamendments devices.'' These devices are 
classified automatically by statute (section 513(f) of the FD&C Act) 
into class III without any FDA rulemaking process. These device types 
remain in class III and require premarket approval, unless and until:
    1. FDA reclassifies the device type into class I or II;
    2. FDA issues an order classifying the device type into class I or 
II in accordance with section 513(f)(2) of the FD&C Act, as amended by 
FDAMA; or
    3. FDA issues an order finding the device to be substantially 
equivalent, under section 513(i) of the FD&C 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 FD&C Act 
(21 U.S.C. 360(k)) and 21 CFR part 807 of the regulations.
    Reclassification of classified postamendments devices is governed 
by section 513(f)(3) of the FD&C Act. This section provides that FDA 
may initiate the reclassification of a device classified into class III 
under section 513(f)(1) of the FD&C 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

[[Page 68201]]

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 FD&C 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.
    Following the effective date of this final rule, 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.

II. Regulatory History of the Device

    An FFDM system is a postamendments device classified into class III 
under section 513(f)(1) of the FD&C Act. This generic type of device 
cannot be placed in commercial distribution unless it is reclassified 
under section 513(f)(3) of the FD&C Act or subject to an approval of a 
premarket approval (PMA) application under section 515 of the FD&C Act 
(21 U.S.C. 360e). In accordance with section 513(f)(3) of the FD&C Act 
and based on information regarding the device, FDA, on its own 
initiative, is reclassifying this device type from class III to class 
II when intended to produce planar digital x-ray images of the entire 
breast. This generic type of device may include digital mammography 
acquisition software, full-field digital image receptor, acquisition 
workstation, automatic exposure control, image processing and 
reconstruction programs, patient and equipment supports, component 
parts, and accessories. Consistent with the FD&C 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.
    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 a 
special controls guidance document, in addition to general controls, 
would provide reasonable assurance of the safety and effectiveness of 
the device (Ref. 1).
    Accordingly, in the Federal Register of May 30, 2008 (73 FR 31040), 
FDA issued a proposed rule to reclassify the device, full-field digital 
mammography system, from class III (premarket approval) into class II 
(special controls). FDA invited interested persons to comment on the 
proposed rule by August 28, 2008.
    A second meeting of the Panel was held on November 17, 2009. This 
meeting was called because the comments received on the proposed rule 
raised the following new questions: Are separate data needed to 
demonstrate the equivalence of FFDM for screening and diagnosis 
indications? Are statistically significant clinical studies needed to 
demonstrate equivalence or can equivalence be demonstrated with 
laboratory and phantom studies along with limited clinical 
demonstrations? Are clinical data on various subgroups necessary to 
demonstrate equivalence?
    The Panel unanimously recommended that the FFDM system be 
reclassified from class III to class II (special controls). The Panel 
also indicated that separate data are necessary for screening and 
diagnostic claims; that laboratory and phantom studies with limited 
clinical demonstration are adequate to establish equivalence; and that 
subcategory analysis is unnecessary.

III. Summary of Final Rule

    The final rule contains revisions to the identification of the 
device type, FFDM system in the draft classification regulation, 21 CFR 
892.1715. The final rule uses the term ``planar'' instead of ``full-
field'' to describe digital x-ray images of the entire breast. The 
sentence stating what the generic type of device may include was 
revised by adding automatic exposure control, image processing and 
reconstruction programs, patient and equipment supports, component 
parts, and accessories, and by eliminating signal analysis programs. 
This change was made to clarify the description by explicitly listing 
aspects of the device and excluding signal analysis programs that are 
contained within the display devices, which are regulated separately. 
Display devices are not part of the FFDM system but rather are separate 
class II devices. The identification now reads: Intended to produce 
planar digital x-ray images of the entire breast. This generic type of 
device may include digital mammography acquisition software, full-field 
digital image receptor, acquisition workstation, automatic exposure 
control, image processing and reconstruction programs, patient and 
equipment supports, component parts, and accessories.

IV. Comments and FDA's Response

    During the public comment period, 23 respondents submitted 
comments. The comments included manufacturers, professional 
organizations, trade associations, and individual medical 
professionals. All comments supported the reclassification of the FFDM 
system from class III (premarket approval) to class II (special 
controls).
    (Comment 1) One comment suggested that the identification's use of 
the term ``signal analysis'' can be confusing in the context of FFDM 
systems and suggested that some items were not completely incorporated 
into the FFDM identification from the film/screen identification that 
should have been incorporated for clarity. The comment suggested that 
the regulation use the following identification to address those 
concerns: 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 acquisition software, full-field digital image receptor, 
acquisition workstation, automatic exposure control, and image 
processing and reconstruction programs, patient and equipment supports, 
component parts, and accessories.
    (Response) FDA agrees with the comment and has revised the 
identification to be similar to the language suggested by the comment.

V. FDA's Conclusions

    Based on the information discussed in the preamble to the proposed 
rule (73 FR 31040) and comments on the proposed rule and draft special 
controls guidance, FDA concludes that special controls, in addition to 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the full-field digital mammography system. The Agency 
is reclassifying the full-field digital mammography system from class 
III (premarket approval) to class II (special controls) when intended 
to produce planar digital x-ray images of the entire breast. This 
generic type of device may include digital mammography acquisition 
software, full-field digital image receptor, acquisition workstation, 
automatic exposure control, image processing and reconstruction 
programs, patient and equipment supports, component parts, and 
accessories.

[[Page 68202]]

    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of the 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 
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 the special controls guidance document. 
The recommended mitigation measures are identified in the second column 
of table 1 of the special controls guidance document.

VI. 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.

VII. 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 (Pub. L. 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 not a significant regulatory action 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. Because classification of this device into class II 
will relieve manufacturers of the cost of complying with the premarket 
approval requirements of section 515 of the FD&C Act and may permit 
small potential competitors to enter the marketplace by lowering their 
costs, the Agency certifies that the final 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 $135 million, using the most current (2009) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    FFDM devices are intended to produce planar digital x-ray images of 
the entire breast. This generic type of device may include digital 
mammography acquisition software, full-field digital image receptor, 
acquisition workstation, automatic exposure control, image processing 
and reconstruction programs, patient and equipment supports, component 
parts, and accessories. Based on the history of use of this type of 
device since the first PMA was approved in 2000, FDA concludes that 
reclassification from class III into class II (special controls) would 
ensure safety and effectiveness of these devices without undue 
regulatory burden. Manufacturers must address the issues identified by 
the special controls guidance document. Manufacturers of new or 
modified FFDM devices would be subject to premarket notification 
requirements, but the burden of submitting a 510(k) would be 
substantially less than that of preparing a PMA.

VIII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. Section 4(a) of the Executive order 
requires agencies to ``construe * * * a Federal statute to preempt 
State law only where the statute contains an express preemption 
provision or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.'' Federal law includes an express preemption provision 
that preempts certain State requirements ``different from or in 
addition to'' certain Federal requirements applicable to devices. 21 
U.S.C. 360k; See Medtronic v. Lohr 518 U.S. 470 (1996); Riegel v. 
Medtronic, 552 U.S. 312 (2008). The special controls established by 
this final rule create ``requirements'' to address each identified risk 
to health presented by these specific medical devices under 21 U.S.C. 
360k, even though product sponsors may have flexibility in how they 
meet those requirements. Cf. Papike v. Tambrands, Inc., 107 F.3d 737, 
740-42 (9th Cir. 1997).

IX. Paperwork Reduction Act of 1995

    This final rule establishes as special controls a guidance document 
that refers to previously approved collections of information found in 
FDA regulations. These collections of information are subject to review 
by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520). Elsewhere in this issue of 
the Federal Register, FDA is issuing a document announcing the 
availability of the guidance document that will serve as the special 
control for this device. That document contains an analysis of the 
paperwork burden for the guidance document.

X. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but we are not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)
    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., C. Gatsonis, E. Hendrick, 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., A. Bloomquist, G. Mawdsley, 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., K. Chakrabarti, R. Kaczmarek, 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, May 23, 2006.

List of Subjects in 21 CFR Part 892

    Medical devices, Radiation protection, X-rays.

[[Page 68203]]

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
892 is amended as follows:

PART 892--RADIOLOGY DEVICES

0
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.

0
2. 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 planar digital x-ray images of the entire 
breast. This generic type of device may include digital mammography 
acquisition software, full-field digital image receptor, acquisition 
workstation, automatic exposure control, image processing and 
reconstruction programs, patient and equipment supports, component 
parts, and accessories.
    (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 Sec.  892.1(e) for the availability of this guidance 
document.

    Dated: November 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-28007 Filed 11-4-10; 8:45 am]
BILLING CODE 4160-01-P