[Federal Register: January 13, 2004 (Volume 69, Number 8)]
[Notices]
[Page 1988-1989]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ja04-54]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0002]
Draft Guidance for Industry and FDA Staff; Saline, Silicone Gel,
and Alternative Breast Implants; 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availability of the draft guidance document entitled ``Saline, Silicone
Gel, and Alternative Breast Implants.'' This version of the draft
guidance document updates preclinical, clinical, and labeling
recommendations described in ``Guidance for Saline, Silicone Gel, and
Alternative Breast Implants'' dated February 11, 2003. The update is
based on the latest scientific and medical information on breast
implants, and clarifies the type and amount of scientific data that
should be submitted to allow FDA to evaluate whether these devices are
safe and effective. The draft guidance document contains new
recommendations for manufacturers submitting applications for premarket
approval of breast implants. Some of the recommendations apply to all
premarket approval applications for breast implants, while others are
specific to the type of implant. The draft guidance document is not
final nor is it in effect at this time.
DATES: Submit written or electronic comments on this draft guidance by
April 12, 2004.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``Saline, Silicone Gel, and
Alternative Breast Implants'' 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 one self-addressed adhesive
label to assist that office in processing your request, or fax your
request to 301-443-8818. 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Submit written comments concerning this draft guidance to the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.fda.gov/dockets/ecomments. Identify comments
with the docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Samie Allen, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 139.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is revising the guidance document entitled ``Saline, Silicone
Gel, and Alternative Breast Implants'' to clarify the type and amount
of scientific data that should be submitted to allow FDA to evaluate
whether these devices are safe and effective. The draft guidance
document provides updated information based on the latest scientific
and medical information on breast implants. The draft guidance document
contains new recommendations for manufacturers submitting applications
for premarket approval of breast implants. Some of the recommendations
apply to all premarket approval applications for these devices, while
others are specific to silicone gel-filled, saline-filled, or
alternative implants. The proposed changes are primarily to the
mechanical data, clinical data, and labeling sections of the draft
guidance document. In addition, a new section entitled ``Modes and
Causes of Rupture'' has been added
[[Page 1989]]
that describes the type of data FDA recommends a manufacturer provide
to address this issue (this section replaces the previous Retrieval
Study section). When final, this draft guidance document will supersede
``Guidance for Saline, Silicone Gel, and Alternative Breast Implants,''
dated February 11, 2003.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices (GGPs) regulation (21 CFR 10.115). The draft
guidance, when finalized, will represent the agency's current thinking
on ``Saline, Silicone Gel, and Alternative Breast Implants.'' 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 ``Saline, Silicone Gel, and Alternative Breast
Implants,'' you may either send a fax request to 301-443-8818 to
receive a paper copy of the document, or send an e-mail request to
GWA@CDRH.FDA.GOV to receive a paper copy or an electronic copy. Please
use the document number (1239) to identify the guidance you are
requesting.
Persons interested in obtaining a copy of the draft 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 submissions, 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 (44 USC 3501-3520) (the PRA). The
collections of information addressed in Sections 3 through 10 of the
guidance document have been approved by OMB in accordance with the PRA
under the regulations governing premarket approval applications (21 CFR
part 814, OMB No. 0910-0231). The labeling provisions addressed in
Section 11 of the guidance document have been approved under OMB No.
0910-0485.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this document
on or before April 12, 2004. Submit a single copy of electronic
comments to http://www.fda.gov/dockets/ecomments. Submit two paper
copies of any mailed comments, except that individuals may submit one
copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. Comments received may be seen
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: January 7, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-658 Filed 1-12-04; 12:00 pm]
BILLING CODE 4160-01-S