[Federal Register Volume 71, Number 225 (Wednesday, November 22, 2006)]
[Notices]
[Pages 67621-67622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-9325]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0002]


Guidance for Industry and Food and Drug Administration 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 guidance entitled ``Saline, Silicone Gel, and 
Alternative Breast Implants.'' This version of the guidance document 
updates preclinical, clinical, and labeling recommendations described 
in ``Guidance for Saline, Silicone Gel, and Alternative Breast 
Implants,'' dated January 13, 2004. 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.

DATES:  Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES:  Submit written requests for single copies 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, 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 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: Nada Hanafi, Center for Devices and 
Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 144.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 13, 2004, FDA issued a draft 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 
comment period closed on April 12, 2004. FDA received over 50 comments. 
FDA is now issuing a finalized update to this guidance document that 
reflects the latest scientific and medical thinking pertaining to 
breast implants, and is based on the April 2005 General and Restorative 
Devices Panel meeting, FDA's review of two premarket approval 
applications for silicone gel-filled breast implants, and comments 
received on the 2004 draft guidance document. The primary changes to 
the guidance document since the 2004 draft version are to the 
Mechanical Data, Device Explant Analyses (formerly Modes and Causes of 
Rupture), and Core Study Clinical Data sections. FDA also combined the 
former two clinical sections. Some of the recommendations in this 
guidance document apply to all premarket approval applications for 
these devices, while others are specific to a type of breast implant 
(i.e., silicone gel-filled, saline-filled, or alternative). This 
guidance document supercedes ``Guidance for Saline, Silicone Gel, and 
Alternative Breast Implants,'' dated February 11, 2003.

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 ``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

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. To receive ``Saline, Silicone Gel, and Alternative 
Breast Implants,'' 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 1239 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 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

[[Page 67622]]

regulations governing premarket approval applications (21 CFR part 814, 
OMB control number 0910-0231). The labeling provisions addressed in the 
guidance have been approved by OMB 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: October 26, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-9325 Filed 11-17-06; 4:30 pm]
BILLING CODE 4160-01-S