[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announcing the availability of the draft guidance document entitled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
[[Page 31042]]
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