[Federal Register: July 28, 2003 (Volume 68, Number 144)]
[Notices]               
[Page 44416-44417]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jy03-129]                         



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0299]

 
Guidance for Industry and FDA Staff; Class II Special Controls 
Guidance Document: Breast Lesion Documentation 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 guidance entitled ``Class II Special Controls 
Guidance Document: Breast Lesion Documentation System.'' This guidance 
document describes a means by which breast lesion documentation systems 
may comply with the requirement of special controls for class II 
devices. Elsewhere in this issue of the Federal Register, FDA is 
publishing a final rule to classify the breast lesion documentation 
system into class II (special controls). This guidance document is 
immediately in effect as the special control for the breast lesion 
documentation system, but it remains subject to comment in accordance 
with the agency's good guidance practices (GGPs).

DATES: Submit written or electronic comments on this guidance at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``Class II Special 
Controls Guidance Document: Breast Lesion Documentation System'' to the 
Division of Small Manufacturers, International, and Consumer Assistance 
(HFZ-220), Center for Devices and Radiological Health (CDRH), Food and 
Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two 
self-addressed adhesive labels to assist that office in processing your 
request, or fax your request to 301-443-8818.
    Submit written comments concerning this 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.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document. See 
the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Colin M. Pollard, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1180.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance describes FDA recommendations to manufacturers of 
breast lesion documentation systems, which are devices that are 
intended for use in producing a surface pressure map of the breast as 
an aid to document palpable breast lesions identified during a clinical 
breast exam. The guidance details FDA's recommendations about software, 
materials, bench testing, and performance characteristics of these 
devices.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying the breast lesion documentation system into 
class II (special controls) under section 513(f)(2) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)). This 
guidance document will serve as the special control for the breast 
lesion documentation system. Following the effective date of the final 
classification rule any firm submitting a 510(k) premarket notification 
for a breast lesion documentation system will need to address the 
issues covered in the special control 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.
    Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act (21 U.S.C. 
360(k)) for a device that has not previously been classified may, 
within 30 days after receiving an order classifying the device in class 
III under section 513(f)(1) of the act, request FDA to classify the 
device under the criteria set forth in section 513(a)(1) of the act. 
FDA shall, within 60 days of receiving such a request, classify the 
device by written order. This classification shall be the initial 
classification of the device. Within 30 days after the issuance of an 
order classifying the device, FDA must publish a notice in the Federal 
Register announcing such classification. Because of the timeframes 
established by section 513(f)(2) of the act, FDA has determined, under 
Sec.  10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible to 
allow for public participation before issuing this guidance as a final 
guidance document. Therefore, FDA is issuing this guidance document as 
a level 1 guidance document that is immediately in effect. FDA will 
consider any comments that are received in response to this notice to 
determine whether to amend the guidance document.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on breast lesion documentation systems. 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

    To receive ``Class II Special Controls Guidance Document: Breast 
Lesion Documentation System'' by fax machine, call the CDRH Facts-On-
Demand system at 800-899-0381 or 301-827-0111 from a touch-tone 
telephone. Press 1 to enter the system. At the second voice prompt, 
press 1 to order a document. Enter the document number (1202) followed 
by the pound sign ([numsign]). Follow the remaining voice prompts to 
complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so by using the Internet. 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 cleared or 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 on the Division of Dockets 
Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). 
The collections of information addressed in the guidance document have 
been approved by OMB in accordance with the PRA under the regulations 
governing premarket notification submissions (21 CFR part

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807, subpart E, OMB control number 0910-0120). The labeling provisions 
addressed in the guidance have been approved by OMB under the PRA 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.

    Dated: July 17, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-19028 Filed 7-25-03; 8:45 am]

BILLING CODE 4160-01-S