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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2008-D-0275]

# AGENCY:

Food and Drug Administration, HHS.

      ( print page 68365)    

# ACTION:

Notice.

# 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 § 892.1715 (21 CFR 892.1715). In order to be classified as a class II device under § 892.1715, a new FFDM system must comply with the                           ( print 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