[Federal Register Volume 59, Number 181 (Tuesday, September 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23152]
[[Page Unknown]]
[Federal Register: September 20, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0318]
Medical Devices; Alternatives to Silicone Breast Implants; Notice
of Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
scientific workshop to discuss draft guidance for manufacturers
concerning testing requirements for alternatives to breast prostheses
containing silicone.
DATES: The public workshop will be held on October 21, 1994, 8:15 a.m.
to 6 p.m. Public participation will take the form of written questions
that may be submitted at the meeting. Written comments regarding the
workshop may be submitted by December 2, 1994.
ADDRESSES: The public workshop will be held at the Omni Shoreham Hotel,
2500 Calvert St. NW., Washington, DC 20028. Advance registration,
including a $40.00 registration fee, is required. A registration form
may be obtained by contacting Sociometrics, Inc., 8300 Colesville Rd.,
suite 550, Silver Spring, MD 20910, 301-608-2151 or 1-800-729-0890 (FAX
301-608-3542). Written comments regarding the workshop may be submitted
to the Dockets Management Branch (HFA-305), Food and Drug
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: John J. Langone or Mary Elizabeth
Jacobs, Center for Devices and Radiological Health (HFZ-113), Food and
Drug Administration, 12709 Twinbrook Pkwy., Rockville, MD 20852, 301-
443-2911 or 301-443-7115, respectively (FAX 301-594-6775).
SUPPLEMENTARY INFORMATION: FDA recognizes that many women needing or
wanting breast implants would like to have a safe and effective
alternative to breast prostheses containing silicone. In addition,
potential manufacturers of these medical devices would like to know the
agency's views on testing requirements for alternative breast implants
intended for reconstruction and/or augmentation. The purpose of the
scientific workshop is to provide a forum for FDA to present draft
guidance concerning alternative breast prostheses testing requirements.
Among the major topics planned for discussion are developments in
biomaterials, chemical characterization of materials, mechanical
testing, preclinical biological testing, clinical testing, quality of
life considerations, requirements for investigational device exemptions
and premarket approval applications, and postmarket-epidemiological
issues. The workshop will include discussion and an exchange of
information by invited scientific authorities.
Dated: September 12, 1994.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 94-23152 Filed 9-19-94; 8:45 am]
BILLING CODE 4160-01-F