[Federal Register Volume 69, Number 8 (Tuesday, January 13, 2004)]
[Notices]
[Pages 1988-1989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-658]


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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Draft Guidance for Industry and FDA Staff; Saline, Silicone Gel, 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availability of the draft guidance document entitled ``Saline, Silicone 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 This version of the draft 
guidance document updates preclinical, clinical, and labeling 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 The draft guidance document contains new 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 The draft guidance document is not 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DATES: Submit written or electronic comments on this draft guidance by 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    Submit written comments concerning this draft guidance to the 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 
[email protected] 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