[Federal Register Volume 75, Number 214 (Friday, November 5, 2010)]
[Notices]
[Pages 68364-68366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28004]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0275]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Full-Field Digital
Mammography System; Availability
AGENCY: Food and Drug Administration, HHS.
[[Page 68365]]
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Class II Special Controls
Guidance Document: Full-Field Digital Mammography System.'' This
guidance document describes a means by which a full-field digital
mammography (FFDM) system may comply with special controls that apply
to these class II devices. Elsewhere in this issue of the Federal
Register, FDA is publishing a final rule to reclassify these device
types from class III into class II (special controls).
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Class II Special Controls Guidance Document: Full-
Field Digital Mammography System'' to the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health (CDRH), Food and Drug Administration,
Bldg. 66, rm. 4613, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to CDRH at 301-847-8149.
See the SUPPLEMENTARY INFORMATION section for information on electronic
access to the guidance.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
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. Background
In the Federal Register of May 30, 2008 (73 FR 31040), FDA issued a
proposed rule to reclassify an FFDM system from class III (premarket
approval) into class II (special controls). Also, in the Federal
Register of May 30, 2008 (73 FR 31128), FDA announced the availability
of the draft guidance entitled ``Class II Special Controls Guidance
Document: Full-Field Digital Mammography System,'' which would serve as
a special control for the device. The comment period on the proposed
rule closed on August 28, 2008.
Following publication of the draft guidance, FDA received a number
of comments. We are responding to comments concerning the guidance in
this document. We are addressing comments concerning the classification
regulation in the preamble to the final rule that is publishing
elsewhere in this issue of the Federal Register.
We reviewed the comments and took their suggestions into
consideration in revising this guidance. The general changes we made to
the guidance in response to the comments included: (1) Changing the
risk of ``incorrect patient positioning'' to ``inadequate breast
coverage''; (2) clarifying when different data are needed for
integrated FFDM systems versus detector-only type FFDM systems; (3)
revising the listed device description requirements for detector only
systems; (4) revising the guidance to consistently use the term
``legally marketed (predicate) FFDM device''; (5) revising the footnote
referring to part 900 (21 CFR part 900), incorporating a tiered
approach to reviewing FFDM devices; and (6) placing greater emphasis on
laboratory testing. The changes we made to the clinical aspects of the
guidance in response to the comments included: (1) Making the suggested
measures less burdensome while providing reasonable assurance of safety
and effectiveness and (2) removing, in some cases, suggested measures
entirely when we believed that our concerns could be addressed by other
measures that we had suggested. The changes we made to the technical
aspects of the guidance in response to the comments included: (1)
Removing the request for description and specifications of the display
from the device description section; (2) removing the request for the
life of the detector and the criteria for replacement and recognizing,
in the section on ``Repeated Exposure Test,'' international standards
(International Electrotechnical Commission) IEC 62220-1-2 and (Final
Draft International Standard) FDIS IEC 61223-3-2 in addition to the
test recommended in Addendum on Digital Mammography: The European
Protocol for the Quality Control of the Physical and Technical Aspects
of Mammography Screening, version 1.0, November 2003; (3) removing the
clause ``whether their [the detector defects] location overlaps the
imaged breast'' and graphical map recommendation and replacing it in
the section now called ``Flat Field Correction and Pixel Defects'' with
the following components: ``the number, spatial distribution (single
pixels, lines, blocks), and types (dead pixel, sensitivity or offset
out of acceptable range) of pixel defects allowed and the rationale for
selecting these criteria; and the methods of compensation for these
defects''; (4) rewording the ``Automatic Exposure Control Performance''
section to ask for data based on tissue thickness only rather than
preselected kilovolt peak, making it clear that the sponsor should only
provide evaluation results for each available Automatic Exposure
Control mode, and removing contrast testing; (5) replacing the request
for ``Bucky factor'' with a request for grid ratio, primary
transmission, selectivity, and contrast improvement factor; (6)
revising section 8 entitled ``Physical Laboratory Testing, Breast
Compression System'' to follow the Mammography Quality Standards Act
(MQSA) guidance for compression force, requesting the manufacturer to
specify the minimum and maximum powered compressive force for their
device and the reasons for choosing the limits, and removing references
to accuracy and limits; (7) revising the ``Noise Analysis'' and
``Physical Measurements'' portion of the guidance to reference
International Standard IEC 62220-1-2, section 6.3.2; (8) revising the
``Signal-to-Noise Ratio Transfer--DQE'' to reference International
Standard IEC 62220-1-2; (9) revising the introduction to the ``Physical
Laboratory Testing'' section to allow greater latitude in choice and be
less prescriptive; (10) removing references to MQSA qualifications from
the ``Phantom Testing'' section; and (11) revising the section
addressing patient radiation dose to remove reference to the ``standard
breast'' and clarifying that FDA seeks phantom data only and reduce the
range of breast sizes from 2 to 8 centimeters (cm) to 2 to 6 cm.
II. Significance of Special Controls Guidance
FDA believes that adherence to the recommendations described in
this guidance document, in addition to the general controls, will
provide reasonable assurance of the safety and effectiveness of the
FFDM system classified under Sec. 892.1715 (21 CFR 892.1715). In order
to be classified as a class II device under Sec. 892.1715, a new FFDM
system must comply with the
[[Page 68366]]
requirements of special controls; manufacturers must address the issues
requiring special controls as identified in the guidance document,
either by following the recommendations in the guidance document or by
some other means that provides equivalent assurances of safety and
effectiveness.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``Class II Special Controls Guidance Document: Full-Field Digital
Mammography System,'' you may either send an e-mail request to
[email protected] to receive an electronic copy of the document or
send a fax request to 301-847-8149 to receive a hard copy. Please use
the document number 1616 to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance 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). The
collections of information in 21 CFR part 807, subpart E, have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 814, subpart B, have been approved under OMB
control number 0910-0231; the collections of information in 21 CFR part
801 have been approved under OMB control number 0910-0485; the
collections of information in 21 CFR part 820 have been approved under
OMB control number 0910-0073; and the collections of information in 21
CFR part 900 have been approved under OMB control number 0910-0309.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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.
Dated: November 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-28004 Filed 11-4-10; 8:45 am]
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