Document ID: FDA-2008-D-0275-0014
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Food and Drug Administration Staff; Availability: Class II Special Controls Guidance Document: Full-Field Digital Mammography System
Posted Date: 2010-11-05T04:00Z

[Federal Register Volume 75, Number 214 (Friday, November 5, 2010)]
[Notices]
[Pages 68364-68366]
From the Federal Register Online via the Government Printing 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 
dsmica@fda.hhs.gov 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]
BILLING CODE 4160-01-P