[Federal Register: August 13, 2001 (Volume 66, Number 156)]
[Notices]
[Page 42545-42546]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au01-65]
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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