[Federal Register Volume 75, Number 214 (Friday, November 5, 2010)]
[Rules and Regulations]
[Pages 68200-68203]
From the Federal Register Online via the Government Publishing 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]
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