[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]
[[Page 44416]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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diskette of the draft guidance document entitled ``Class II Special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
[[Page 44417]]
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