[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availability of a draft guidance entitled ``Guidance on Preclinical and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 This draft guidance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 This draft guidance discusses information relevant to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DATES: Written comments concerning this draft guidance must be received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electronic access to the draft guidance.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single copies on a 3.5'' diskette of the draft guidance entitled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Submit written comments on the draft guidance to the Dockets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
