[Federal Register Volume 73, Number 105 (Friday, May 30, 2008)]
[Notices]
[Pages 31128-31129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-12119]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry and Food and Drug Administration 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.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Class II Special Controls 
Guidance Document: Full Field Digital Mammography System.'' This draft 
guidance document describes a means by which the full field digital 
mammography (FFDM) system may comply with the requirement of special 
controls for class II devices. Elsewhere in this issue of the Federal 
Register, FDA is publishing a proposed rule to reclassify the FFDM 
system device type from class III (premarket approval) into class II 
(special controls). This draft guidance is neither final nor is it in 
effect at this time.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on this draft guidance 
by August 28, 2008.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``Class II Special Controls Guidance 
Document: Full Field Digital Mammography System'' to the Division of 
Small Manufacturers, International, and Consumer Assistance (HFZ-220), 
Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 240-276-3151. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit written comments concerning this draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.regulations.gov. Identify comments with the 
docket number found in brackets in the heading of this document.

[[Page 31129]]


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

    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, 21 CFR 892.2040, and 21 CFR 892.2050 as class II 
devices (special controls). The FFDM system device is currently in 
class III and subject to premarket approval requirements (section 515 
of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
360e)).
    At a public meeting on May 23, 2006, the Radiological Devices Panel 
(the Panel) unanimously recommended that the FFDM system be 
reclassified from class III to class II (special controls). The Panel 
also recommended that class II with a special controls guidance 
document would provide reasonable assurance of the safety and 
effectiveness of the device. FDA considered the Panel's 
recommendations, and elsewhere in this issue of the Federal Register, 
FDA is proposing to reclassify the FFDM system into class II. If the 
reclassification rule is finalized, FDA intends that this draft 
guidance document will serve as the special control for this device.
    Following the effective date of any final reclassification rule 
based on the proposal, any firm submitting a premarket notification 
(510(k)) for an FFDM system would need to address the issues covered in 
the special controls draft guidance document. However, the firm need 
only show that its device meets the recommendations of the draft 
guidance document or in some other way provides equivalent assurances 
of safety and effectiveness.

II. Significance of Guidance

    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, if 
finalized, will represent the agency's current thinking on the FFDM 
system. It does not create or confer any rights for or on any person 
and does not operate to bind FDA or the public. An alternative approach 
may be used if such approach satisfies the requirements of the 
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. 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 240-276-3151 
to receive a hard copy. Please use the document number (1616) to 
identify the guidance you are requesting.
    CDRH maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This draft guidance document 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, and the 
collections of information in 21 CFR part 801 have been approved under 
OMB control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. 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 Division of Dockets 
Management 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.

    Dated: May 21, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-12119 Filed 5-29-08; 8:45 am]
BILLING CODE 4160-01-S