FDA Guidance: Preclinical and Clinical Data and Labeling for Breast Prostheses

The U.S. Food and Drug Administration (FDA) has made available a draft guidance that provides guidance to sponsors of breast implant prostheses on important preclinical, clinical, and labeling information that should be presented in an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.

The document discusses information relevant to silicone gel-filled, saline-filled, and alternative-filled breast prostheses. It is available on FDA's Web site at http://www.fda.gov/cdrh/ode/1354.html.

The draft guidance is intended to combine and replace the following three individual guidances that were previously developed for silicone gel, saline, and alternative breast prostheses: (1) "Draft Guidance for Preparation of FDA Submissions of Silicone Gel-Filled Breast Prostheses" (May 11, 1992); (2) "Draft Guidance for Testing of Alternative Breast Prostheses (Non-Silicone, Gel-Filled)" (September 1, 1994); and (3) "Draft Guidance for Preparation of PMA Applications for Silicone Inflatable (Saline) Breast Prostheses" (January 18, 1995).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, the document involves the revisiting and updating of the scientific preclinical and the clinical and labeling information described in those guidances.

Submit written comments by January 4, 2000, to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.