[Federal Register Volume 64, Number 192 (Tuesday, October 5, 1999)]
[Notices]
[Pages 54028-54029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25771]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-4003]


Medical Devices; Guidance on Preclinical and Clinical Data and 
Labeling for Breast Prostheses; 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availability of a draft guidance entitled ``Guidance on Preclinical and 
Clinical Data and Labeling for Breast Prostheses.'' This draft guidance 
is not final nor is it in effect at this time. The purpose of this 
document is to provide guidance to sponsors of breast implant 
prostheses on important preclinical, clinical, and labeling information 
that should be presented in an investigational device exemptions (IDE), 
a premarket approval (PMA), or a product development protocol (PDP) 
application. This draft guidance discusses information relevant to 
silicone gel-filled, saline-filled, and alternative-filled breast 
prostheses intended for prostheses for breast augmentation, breast 
reconstruction

[[Page 54029]]

following mastectomy, and revision of a failed prosthesis.

DATES: Written comments concerning this draft guidance must be received 
by January 4, 2000.
ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the draft guidance. Submit written requests for 
single copies on a 3.5'' diskette of the draft guidance entitled 
``Guidance on Preclinical and Clinical Data and Labeling for Breast 
Prostheses'' 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.

     Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Samie N. 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

     The purpose of this document is to provide guidance to sponsors of 
breast implant prostheses on important preclinical, clinical, and 
labeling information that should be presented in an IDE, PMA, or PDP 
application. It may also be useful in the preparation of 
reclassification petitions and master files.
     This draft guidance discusses information relevant to silicone 
gel-filled, saline-filled, and alternative-filled breast prostheses 
intended for prostheses for breast augmentation, breast reconstruction 
following mastectomy, and revision of a failed prosthesis. This draft 
guidance does not address tissue expanders, which are unclassified 
devices for temporary use. Additionally, this draft guidance does not 
address alternative shell materials for use in breast implants.
     This draft guidance is intended to combine and replace the 
following three individual guidances that were previously developed for 
silicone gel, saline, and alternative breast prostheses:
     (1) ``Draft Guidance for Preparation of FDA Submissions of 
Silicone Gel-Filled Breast Prostheses'' (May 11, 1992); (2) ``Draft 
Guidance for Testing of Alternative Breast Prostheses (Non-Silicone, 
Gel-Filled)'' (September 1, 1994); and (3) ``Draft Guidance for 
Preparation of PMA Applications for Silicone Inflatable (Saline) Breast 
Prostheses'' (January 18, 1995).
     In addition, this draft guidance involves the revisiting and 
updating of the scientific preclinical and the clinical and labeling 
information described in those guidances.

 II. Significance of Guidance

     This guidance document represents the agency's current thinking on 
preclinical, clinical, and labeling information for breast prostheses. 
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, regulations, or 
both.
     The agency has adopted good guidance practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This guidance document is issued as a Level 1 guidance document 
consistent with GGP's.

 III. Electronic Access

     In order to receive the ``Guidance on Preclinical and Clinical 
Data and Labeling for Breast Prostheses'' via your fax machine, call 
the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-0111 
from a touch tone telephone. At the first voice prompt press 1 to 
access DSMA Facts, at second voice prompt press 2, and then enter the 
document number (1354) followed by the pound sign (#). Then follow the 
remaining voice prompts to complete your request.
     Persons interested in obtaining a copy of the draft guidance may 
also do so using the World Wide Web (WWW). CDRH maintains an entry on 
the WWW for easy access to information including text, graphics, and 
files that may be downloaded to a personal computer with access to the 
WWW. Updated on a regular basis, the CDRH home page includes the draft 
guidance entitled ``Guidance on Preclinical and Clinical Data and 
Labeling for Breast Prostheses,'' 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 on Preclinical and Clinical Data and Labeling for 
Breast Prostheses'' also will be available at http://www.fda.gov/cdrh/
ode/1354.pdf.

 IV. Comments

     Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this draft guidance. Two 
copies of any comments are to be submitted, except individuals may 
submit one copy. Comments should be identified with the docket number 
found in brackets in the heading of this document. A copy of the draft 
guidance 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: September 21, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-25771 Filed 10-4-99; 8:45 am]
BILLING CODE 4160-01-F