[Federal Register Volume 66, Number 156 (Monday, August 13, 2001)]
[Notices]
[Pages 42545-42546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20159]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-4003]


Medical Devices; Guidance for Saline, Silicone Gel, and 
Alternative Breast Implants; Final Guidance for Industry; 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 ``Guidance for Saline, Silicone 
Gel, and Alternative Breast Implants; Final Guidance for Industry.'' 
This guidance provides important preclinical, clinical, and labeling 
information that should be presented in an investigational device 
exemption (IDE), a premarket approval (PMA), or a product development 
protocol (PDP) application for any breast implant.

DATES: Submit written comments at any time.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the guidance document entitled ``Guidance for Saline, Silicone Gel, 
and Alternative Breast Implants; Final Guidance for Industry'' to the 
Division of Small Manufacturers Assistance (HFZ-220), Center for 
Devices and Radiological Health, 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. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit written comments on the document to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

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.

SUPPLEMENTARY INFORMATION:

I. Background

    This final guidance provides important preclinical (chemistry, 
toxicology, and mechanical), clinical, and labeling information that 
should be presented in an IDE, PMA, or PDP application. The information 
discussed is relevant to breast implants filled with silicone gel, 
saline, or alternative filler intended for breast augmentation, breast 
reconstruction, and revision.
    This final guidance serves to update the information provided in 
the draft guidance entitled ``Guidance on Preclinical and Clinical Data 
and Labeling for Breast Prostheses'' (64 FR 54028, October 5, 1999). 
FDA received two comments. The first comment requested FDA to 
strengthen the language used throughout the guidance. The second 
comment involved points to consider with regard to the device 
description, preclinical testing, and clinical sections of the 
guidance. This update is based on our additional scientific review and 
analysis of published studies, reviews of breast implant applications, 
the comments received, and discussions and correspondence between the 
Center for Devices and Radiological Health's Plastic and Reconstructive 
Surgery Devices Branch and breast implant sponsors. Although some minor 
updates were made in the chemistry and toxicological sections of the 
guidance, the primary revisions were to the mechanical testing and 
clinical data sections to reflect our current thinking on these topics. 
Additionally, FDA expanded the labeling section to address all 
essential pieces of labeling. The manufacturing section of the draft 
guidance was deleted because FDA concluded that it did not provide 
necessary information and, instead, wanted the guidance to focus on 
preclinical, clinical, and labeling issues.

[[Page 42546]]

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
preclinical and clinical data and labeling for 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 applicable statute and regulations.
    The agency has adopted good guidance practices (GGPs), and 
published the final rule, which set forth the agency's regulations for 
the development, issuance, and use of guidance documents (21 CFR 
10.115; 65 FR 56468, September 19, 2000). This guidance document is 
issued as a level 1 guidance in accordance with the GGP regulations.

III. Electronic Access

    In order to receive ``Guidance for Saline, Silicone Gel, and 
Alternative Breast Implants; Final Guidance for Industry'' via your 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 (1354) followed by the pound sign (#). Follow the 
remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so 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 the civil money penalty 
guidance documents package, device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh. Guidance documents are also available on the Dockets Management 
Branch Internet site at http://www.fda.gov/ohrms/dockets/default.htm.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments regarding this guidance 
at any time. Submit two copies of any 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. The guidance 
document and received comments are available for public examination in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: August 2, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 01-20159 Filed 8-10-01; 8:45 am]
BILLING CODE 4160-01-S